Retained Search

We have been retained for a newly created Vice President, Global Regulatory Affairs position. This role will be leading my client’s development programs focused on cancer immunotherapy.

Organization: My client is a growing immune-oncology company and leader in T-cell therapies focused on transforming the lives of cancer patients by designing and delivering cell therapies. They are breaking new ground with science and technology, making now a perfect time to join their incredibly collaborative and patient-focused team.

Role: The Vice-President, Global Regulatory Affairs provides strategic and operational leadership to support product development across the organization. In this role, you will lead interactions with global regulatory agencies, coordinate with internal senior stakeholders, and manage and direct all regulatory strategic and operational initiatives.

Responsibilities:

• Provide global regulatory leadership supporting the global development, registration, and life-cycle management of programs.
• Responsible for oversight of the health agency meetings (FDA, EMA, etc.) and strategic planning. 
• Proactively participate in the design of US and ex-US regulatory strategies for the development of cell therapy products for oncology.
• Supervise the work of all Regulatory Affairs team members, both internal, and external and manage external vendors supporting the Regulatory Affairs function.
• Actively engages with industry organizations (ARM, DIA, RAPS, etc.) to drive cross-industry best practices and support evolving global regulatory guidance.
• Oversees regulatory staff and participates in skill development, coaching, and performance feedback of regulatory staff.
• Drive adherence to regulatory requirements and guidelines.
• Participate in due diligence activities on potential licensing, acquisition, or collaboration opportunities.
• Reviews and establishes standard operating procedures (SOPs) and global regulatory affairs processes and proactively contribute to the company compliance initiatives.
• Proactively forecast and manage the budget for Regulatory Affairs.
• Represent the company at appropriate regulatory and scientific conferences.
• Perform regulatory intelligence activities – monitor regulatory changes and competitor trends/strategies.

Qualifications & Experience:

• Experience in cell and gene therapy and/or oncology.
• Bachelor’s Degree preferably in science-related discipline, Advanced Degree preferred.
• At least 15-20 years of Global Regulatory Affairs experience.
• Track record of leading regulatory activities for development program(s).
• Experience with successful marketing applications (BLAs/NDAs/MAAs).
• Proven leadership and management experience of regulatory staff.
• Experience leading regulatory interactions, including formal meetings.
• Experience working in a matrix team environment.
• Familiarity with in-vitro diagnostic device regulations.
• Well-versed in regulatory strategy and regulatory science writing.
• Extensive knowledge in ICH, FDA, EMA, and international regulations/guidelines, including those related to cell and gene therapy.
• Companion diagnostic experience (IDE, PMA) preferred.

#retainedsearch #regulatoryaffairs #oncology #celltherapy #genetherapy # immunotherapy #cart #vicepresident #remote #globalregulatoryaffairs #lifesciences #regulatoryaffairsrecruiter #in-vitrodiagnostic

Retained Search

Our client is an established and growing Global Medical Device/Technology company fueled by knowledge, passion, collaboration, and integrity. With operations in Australia, Europe, the US and Aisa.  In this role You will be responsible for developing and leading the Regulatory strategy and providing strategic an operational leadership to the organization.  The Head of Regulatory affairs will be accountable for prioritizing the pipeline, and overseeing programs through development for regulatory approval, as well as life cycle management opportunities for already approved and marketed products. This is an exciting time to join this established, growing organization.

Responsibilities:

• Lead global regulatory oversight and support of the global development, registration, and life-cycle management of programs.
• Responsible for oversight of the health agency meetings (FDA, EMA, TGA, MHRA etc.) and strategic planning.
• Providing regulatory advice to the business as it impacts the commercialization strategy of the company’s products.
• Lead global oversight and support of the organization’s regulatory compliance initiatives including:
• Identify and monitor current regulatory requirements the QMS must satisfy to operate legally within the jurisdictions company targets for product release.
• Represent company with senior customer representatives, partners, regulators, suppliers, associations, or other bodies as required.
• Engage consulting services in support of the role’s responsibilities where appropriate.
• Actively engages with industry organizations (ARM, DIA, RAPS, etc.) to drive cross-industry best practices and support evolving global regulatory guidance.
• Engage with company leadership roles such as the Global Quality Manager and GM-NPI for the establishment of efficient and effective business systems for the delivery of compliant product to customers.
• Manage all necessary engagement with Notified Bodies to support products in market.
• Support the company’s due diligence on potential acquisitions in regulatory matters.
• Provide input to the business units and reporting to the CCSO, including via Management Review process, recommendations for improvement and emerging regulatory compliance risk and mitigation.

Qualifications:

• B.S./B.A. in a science, engineering, or related technical field is required, Regulatory Affairs Certification a plus.
• Minimum 10 years’ experience in a senior regulatory affairs leadership role which encompasses a close working relationship with the FDA for medical device or combination products.
• Excellent oral communication skills and demonstrated ability to present, influence and create solid partnerships with executive leaders and regulatory agencies and trade associations.
• Proven success in building, development and driving team success.
• Inspiring leader that creates energy, enthusiasm and delivery of simultaneous high impact projects and results.
• Previous experience in a Quality Assurance capacity with responsibility for regulatory compliance and continuous improvement initiatives in a science based and/or technologically sophisticated manufacturing environment.
• An in-depth working understanding of Quality Management Systems, ISO 13485 and/or equivalent to support MD/IVD products (class 2 or higher preferred).
• Experience in partnering with internal and external stakeholders on key issues or submissions.
• An expert level understanding of Compliance and Risk Management (ISO14971 preferred).
• A strong commercial acumen with an ability to apply regulatory requirements in commercial environment.
• Ability to represent the company appropriately with senior customer representatives, partners, regulators, suppliers, associations, or other bodies as required.

#medicaldevice #quality #medicaldevicequality #retainedsearch #regulatoryaffairs #qualityassurance #leadership #qualitymanagmentsystems #qms #globaldevelopment #regulatoryaffairsrecruiter

My client is seeking a highly motivated Regulatory Affairs professional to join their growing organization. In this role, you will be responsible for supporting global regulatory submissions and ongoing regulatory compliance through the product development lifecycle. This is the perfect opportunity for a regulatory professional who is looking to take the next step in their career.

Responsibilities:

• Independently prepare global regulatory applications, including U.S. Medical submissions (Pre-Submissions, 510Ks, IDEs, and applicable supplements and annual reports), Canadian Class 2 Device License submissions, EU MDR Submissions, and other international markets.
• Participate in compliance activities, such as internal audits, FDA and Notified Body audits, complaint handling, and vendor audits.
• Assist in preparing or updating documentation and labeling as required. 
• Assist in coordinating regulatory documentation such as device listings, certificates to foreign governments, and Canadian medical device licensing.
• Prepare materials for Management Review Meetings.
• Prepare and maintain the regulatory product classifications and groupings for new products within the context of the Medical Device Directive.
• Embed with Design/Development teams to provide both technical and RA input with a view to ensuring that design documentation resultant from the design-development process can be utilized for 510(k) and Technical Files with minimal (to no) modification.
• Write technically compelling essays to submit to FDA to prove substantial equivalency

Requirements:

• BS/BA, preferably in engineering or life sciences.
• 5+ years of experience with US and EU regulatory preparations and submissions.
• Experience in Class II electro-mechanical medical devices.
• Hands-on knowledge in preparing and submitting Clinical Evaluation Reports, Medical Device Regulation submissions, 510K preparations and submittals, ongoing reporting to Medical Device regulatory agencies and knowledge of other international regulatory requirements.
• Excellent organizational, technical writing, and communication skills.
• Proficiency with Microsoft Office.
• Knowledge of ISO 13485, 21 CFR Part 820, MDSAP, and EU MDR.
• Experience drafting 510(k) documentation and EU Technical Documentation.

#medicaldevice #regulatoryaffairs #510K #classII #electromechanical #lasers #electro-mechanical #newposition #productdevelopment #fda #mdr #eu

Retained Position

We have a newly created opportunity for a Sr. Global Regulatory Lead will be the primary contact for strategic oversight on the respective therapeutic area as the subject matter expert. Responsible for leading regulatory strategic decision making that enables a project to meet its business and regulatory deliverables.

Organization: My client is an established, world-class biotherapeutics organization with operations in 35+ nations and 22,000 employees worldwide. They are driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation, and burn treatment. With a passion and commitment to delivering on their promise to save and improve lives across the globe, now is an exciting time to join this team.

Responsibilities:

• Providing innovative scientific and regulatory vision, and leadership in defining aligned global regulatory strategies for assigned products within developmental portfolio and accountable for clinical and safety content globally of regulatory documentation for these projects.
• As the primary regulatory interface within for Global Regulatory Affairs (GRA) on specific projects, the incumbent will have responsibility for ensuring collaboration with key internal stakeholders of the Core Project Team (CPT), Clinical Development Team (CDT), Safety Management Team (SMT) and Commercial Development to ensure the global regulatory strategy is an integral component of stakeholder deliverables.
• For early development projects, the Sr. GRL is a company resource for global regulatory perspective and drives the GRA perspective within the company.
• The Sr. GRL leads the Global Regulatory Affairs Strategy Team (GRAST) for assigned projects to ensure the development and delivery of innovative, science-based, solution-oriented, and globally aligned regulatory strategy.
• In partnership with GRA Regional Leads, supporting the establishment and maintenance of high quality working relationships with the FDA, EMA, PMDA and other global regulatory agencies.

Qualifications and Experience:

• A bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is required. An advanced degree (MS/MBA, PhD or MD) is preferred.
• Minimum of 10 years’ experience in the biotech or pharmaceutical industry, with at least 8 years in Regulatory (with 5+ years of that time in a developmental stage organization).
• Experience in leading and managing Health Authority meetings.
• Candidates must have thorough knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one key region (i.e., EU, US, Japan)
• Experience working within the regulatory affairs (regional, clinical or CMC) in a global environment across two or more geographic areas (preferentially US and EU), with proven skill implementing successful global regulatory strategies.
• Experience interfacing with regulatory agencies, including leading and preparing the sponsor’s team for an interaction.
• Demonstrated experience in working with multiple stakeholders, across geographies.
• Experience working in a complex and matrix environment is required.
• Prior clinical regulatory foundation is preferred.

#retainedsearch #regulatoryaffairs #newposition #lifesciences #biotech #grl #clinicaldevelopment #drugdevelopment #director #regulatoryaffairsrecruiter #fda

Retained Search

Our client is a clinical-stage biotechnology company leveraging its immune tolerance platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses. The Senior Director will be accountable for driving the development of innovative CMC regulatory strategies and the preparation and submission of high-quality CMC sections of INDs, IMPDs, CTAs, and original marketing applications (BLAs/MAAs).

Responsibilities:

• Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends.
• Excellent knowledge of ICH requirements for the Quality aspect of the development of large molecules.
• Lead early development (Pre-IND) to registration and commercialization in the US and EU and other major markets.
• Develop documents for IND and BLA submissions in eCTD format.
• Writing and reviewing CMC regulatory documents to support global filings such as IND/IMPD, BLA, MAA,v5  and equivalent.
• Writing and reviewing briefing packages for meetings with regulatory bodies (US FDA, EMA, and others)
• Actively collaborates with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners, and CROs) to develop and execute robust CMC regulatory strategies.
• Experience in successfully leading the CMC component of meetings with major regulatory bodies such as FDA and EMA.
• Interpret GMP-related matters and review of CMC aspect of regulatory documents.
• Manages and or mentors staff members.
• Ability to significantly contribute to both developmental and commercial (marketed product) teams.

Qualifications:

• A Masters’ degree in biology, biochemical engineering, biochemistry or analytical chemistry, or related subject (Ph.D. preferred).
• 10+ years of Regulatory CMC experience with large molecules (biotechnology products) with FDA or biotechnology industry or combination.
• Experience with large molecules (therapeutic proteins produced by recombinant DNA technology).
• Extensive experience in developing documents for IND and BLA submissions in eCTD format.
• Experience also with gene therapy products is a plus.
• Experience in writing and reviewing CMC regulatory documents to support global filings such as IND/IMPD, BLA, MAA.
• Experience in the development and review of CMC regulatory documents for small molecules.
• The ability of independent thinking and decision making in collaboration with team members.
• Can do attitude and being excited about bringing new treatments to patients faster.
• Ability to interpret GMP related matters and review of CMC aspect of regulatory documents.
• Ability to independently plan, execute and manage regulatory submissions for assigned products in clinical development, during global registrations, and post-approval life cycle activities.
• Expertise in reviewing documents pertaining to due diligence for new business opportunities.
• Outstanding oral and written communication and negotiating skills.

#cmc #regulatorycmc #seniordirector #regulatoryaffairs #lifesciences #retainedsearch #biologics #bla #newposition #regulatoryaffairsrecruiter

Remote Position

Shepherd Regulatory Search has been engaged for a newly created Associate Director Global Regulatory Affairs position. In this role, you will be the point of contact for all agency interactions.

Organization: Our client is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative treatments for severe, rare muscle disorders for which there is a significant unmet medical need.

Primary Responsibilities:

• Oversees the writing, editing, reviewing, and compiling documents needed for regulatory submission activities for US and global assigned products, responsible for all areas of communication with FDA and global agencies
• Provides critical review of all documentation supporting regulatory submissions and communications
• Prepares and submits regulatory applications, annual reports/IND amendments, and meeting requests to FDA and European regulatory agencies
• Reviews and prepares responses to requests from regulatory authorities
• Provides leadership for regulatory document management systems and maintains corporate regulatory files.
• Ensures regulatory milestones are met to support regulatory submission and overall business goals of the Company,
• Contribute to the development of regulatory strategies
• Leads regulatory operations efforts for development programs by working closely with internal functional teams, external vendors, and consultants
• Oversees the external vendors and contractors with responsibility for providing regulatory support to ensure goals are achieved
• Primary liaison with regulatory agencies § Interacts with senior management to report on project or program milestones
• Provides strategic or operational input on project team
• Builds professional and effective external relationships crucial to the success of the organization
• Works across internal departments to maintain credibility, trust, and support of employees and other stakeholders

Requirements:

• BS/BA degree in a scientific/health sciences discipline
• 7+ year’s experience in pharmaceutical Regulatory Affairs
• Experience in the preparation of submissions, regulatory documents, annual reports, amendments, and supplements
• Proven ability to strategize with team members on the optimal way of documenting various submissions and determining the preferred plan
• In-depth knowledge of overall global drug development, expertise on the timeline and process for submissions
• Expert knowledge of regulations and guidance’s affecting routine regulatory activities and specific therapeutic areas and keeps abreast of the regulatory environment
• In-depth knowledge of overall global drug development
• Excellent written, interpersonal and communication skills
• Action-oriented and committed to meeting FDA and other regulations while moving projects forward
• Able to handle changing priorities and multidisciplinary tasks
• Easily gains trust and support of peers; encourages collaboration

#remote #regulatoryaffairs #newposition #associatedirector #raredisease #muslcledisorder #regulatorystrategy #lifesciences #regulatoryaffairsrecruiter #drugdevlopment #clinicaltrials ##duchenne #musculardystrophies

We have been engaged for a Director of Quality Assurance position. In this role, you will oversee and manage the overall quality organization, including design assurance, manufacturing quality, and audit compliance. The Director of Quality Assurance will ensure compliance with applicable regulations and standards and play a crucial role in ensuring safety, efficacy, and compliance.

Responsibilities:

• Oversee and manage the overall quality organization, including design assurance, manufacturing quality, and audit compliance.
• Ensure compliance with applicable regulations and standards, including FDA 21 CFR Part 820, ISO 13485, Health Canada, and European MDRs.
• Manage all aspects of the Quality Management System (QMS), including the Quality Manual and procedures/processes, such as document and data control, quality planning, training, vendor approval/monitoring, equipment maintenance and calibration, complaint handling and trending, product recalls/advisory notices, corrective and preventive action system, non-conforming materials, and incoming and final inspection.
• Manage design control activities for new and sustaining product development efforts, including risk analysis activities, such as design and process FMEA, design and process (IQ/OQ/PQ) validation/verification activities, and software validation.
• Oversee sterilization validation & biocompatibility compliance testing for single-use disposable and reusable accessories.
• Manage the clean room environment for single-use and reusable accessory processing, including certification and maintenance to international standards.
• Conduct internal and external audits of the Quality System.
• Represent the QMS internally (Authorized Management Representative) and to external customers.
• Report on the performance of the quality management system to senior management.

Requirements:

• Bachelor’s degree in a scientific, biomedical, or engineering discipline.
• 15 years of experience in Medical Device Quality Assurance, with a minimum of 5 years of hands-on management experience.
• Design Assurance experience.
• Experience with electro-mechanical medical devices.
• New product development, medical devices.
• Solid knowledge of applicable regulations, such as FDA 21 CFR Part 820 and ISO 13485, is required.
• Proven experience in building and leading technical teams.
• Solid knowledge of global regulatory requirements/standards.
• Direct experience in development and oversight of Quality Management Systems.
• Excellent interpersonal effectiveness and written/verbal listening/communication skills.
• Ability to evaluate and reorganize priorities quickly in a dynamic start-up environment.
• Excellent interpersonal skills and ability to gain respect and develop good working relationships with cross-functional personnel at all levels.

#qualityassurance #designassurance #medicaldevice #electro-mechanical #electromechanical #imaging #laser #director #newposition #qualityauditing #iso3485 #regulatoryaffairsrecruiter

Our client has engaged us for a full-time permanent Nonclinical Consultant position. They are seeking a mid-level experienced scientific professional with a strong nonclinical study monitoring background to join their team of experienced professional toxicology consultants. Organization: A scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of pharmaceuticals and medical devices, and they are looking to expand their regulatory affairs consultant team with an experienced scientific professional with strong interpersonal skills.

Responsibilities:
•Manage all aspects of outsourced nonclinical studies including study design, competitive bidding, pre-study activities, study monitoring, data, and report review.
•Monitor the studies including site visits, as needed, to ensure scientific, regulatory, compliance, and animal welfare regulations expectations are met, and quality reports are delivered on an agreed-upon timeline.
•Provide technical and scientific nonclinical study advice for a wide range of study designs, routes of administration, and species commonly used in drug development.
•Provide regulatory toxicology support to clients.
•Author reports and/or regulatory documents as needed.
•Interact with clients and vendors.
•Provide scientific and innovative advice to internal and external parties.
•Participate in business development activities.

Knowledge and Skills:

•Bachelor’s degree, in a scientific field (e.g., biology, chemistry, biochemistry, etc.), is required.
•Prior experience in Study Directorship or coordination in a Contract Research Organization (CRO) is highly desired.
•A minimum of 4 years in the pharmaceutical/biotechnology industry, CRO, and/or consulting with significant study monitoring experience.
•Good understanding of technical study conduct, study design, procedures, and documentation practices and regulatory requirements.
•Proven knowledge of Good Laboratory Practices (GLP).
•Demonstrated organizational and project management skills.
•Strong computer skills (e.g. Microsoft Word, Excel, PowerPoint, etc.).
•Ability to work independently and within a group setting and to interact effectively with different functional areas.
•Excellent communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.

#nonclinical #studydirector #studydesign #glp #toxicology #studyconduct #remote #regulatoryaffairsrecruiter #studymonitor

Consulting Position - Remote - Long Term

Our client is one of the world’s premier biopharmaceutical companies. With a commitment to science, medicine, research, and development focused on patients’ needs and unmet challenges. In this role, you will lead Regulatory Affairs initiatives to ensure all promotional items are prepared and executed in accordance with applicable regulations and guidelines and company policy. This is a 6-month engagement, 40 hours a week.

Job Summary:

• Oversees regulatory guidance provided by team to ensure compliance with promotional regulations.
• Responsible for Global Processes and applications of codes and regulations for Global review of products.
• Oversight/Accountable for all submissions within group.
• Approve enforcement responses.
• Manages personnel within group to ensure coverage for brand and therapeutic area responsibilities.
• Understand and interpret complex scientific issues related to regulatory requirements and promotional strategy. Able to mentor and develop skills of staff.
• Understands broad concepts within regulatory affairs and implications across organization.
• Offers creative solutions and strategies, including risk mitigation strategies.
• Develops strategy for efficient and appropriate OPDP review and play a key role in life cycle management strategy.
• Reviews competitive materials and interacts with FDA to urge enforcement activity as necessary.
• Responsible for development and training of global review processes.
• Works closely with Medical, Legal, OEC, Marketing, Marketing Operations, Sales, and Sales Training departments as well as external advertising agencies and consultants in the successful development of promotional and applicable training materials.
• Support development and maintenance of product labeling with Regulatory Affairs Labeling and Strategy groups.
• Lead for Promotion and Advertising Regulatory Review for licensing opportunities

Qualifications:

• BS/BSc preferred; BA accepted, PharmD preferred.
• 8 years industry with 6 years regulatory or related experience.
• Previous experience in Regulatory Affairs promotion and advertising; experience in managing major regulatory filing(s) e.g. Launch Advisory Materials or responses to enforcement letters.
• Prior people management experience not required but preferred.
• Extensive knowledge of applicable FDA regulations.
• Able to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for the development of marketing materials.
• Understands regulatory, quality, and safety systems impacting drug development and marketed product support.
• Functions independently as a decision-maker on regulatory issues.

#consulting #contract #remote #advertising #promotion #regulatoy #regulatoryaffairs #opdp #regulatoryadvertisingpromotion #newposition #regulatoryaffairsrecruiter #regulatoyreview

Regulatory Consulting Position - Long term - Remote 

The Global Regulatory Lead Consultant will be responsible for developing and directing the global regulatory strategy, objectives, policies, and programs pertaining to the development and marketing of drug and/or biological products. The GRL will be responsible for global registration and life cycle support and includes the leadership of regulatory strategy for multiple projects that extend globally (United States, EU, ROW, etc.).  

Responsibilities:

• Leads the development of strategic plans and tactical implementation leading to the creation and submission of regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs, and other relevant regulatory filings.
• Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings. Oversees direct reports as needed.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Lead regulatory reviewer in due diligence for licensing opportunities.
• Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.

Requirements:

• BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
• 8+ years of Regulatory experience, including equivalent experience in the biopharmaceutical industry.
• 2-5 years of management experience preferred.
• Regulatory experience should be broad (across the life cycle of pharmaceutical products and across main regions such as the US, EU, Japan and Canada) to ensure appropriate leadership and mentoring for regulatory staff referred experience in reviewing, authoring, or managing components of regulatory submissions.
• Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW, and post-marketing a plus.
• Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.
• Strong oral and written communication, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
• Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategy/
• Must work well with global teams.

    #regulatoryaffairs #contractor #consulting #regulatoryconsulting #remote #fda #newposition #globalregualtory #regulatoryaffairsrecruiter #lifesciences #biotech #pharma #drugdevelopment

Retained Search

We have been retained on a newly created Head of Regulatory Policy & Intelligence. Reporting to the VP, Global Quality and Regulatory Affairs, the Head of Regulatory Policy will provide strong leadership and strategic direction for Regulatory strategy including the development of a global framework to facilitate and drive Regulatory as a strategic lever. As a member of the Quality and Regulatory Leadership Team, as well partnering closely with the Divisional Regulatory leaders, the Head of Regulatory Policy & Intelligence will be instrumental in facilitating all global regulatory positioning.

Organization: My client is an established and growing Medical Technology company fueled by knowledge, passion, collaboration, and integrity. As a global champion of women’s health, they are focused on improving women’s health and well-being through early detection and treatment.

Job Summary:  The Head of Regulatory Policy & Intelligence is an effective and inspiring influencer with the capability to create followership and to create transparent understanding and guidance to ensure compliance and speed of decisions such that regulatory is a facilitator for growth. Will create confidence and credibility as a trusted partner to business leaders across different functions to build a culture and community of regulatory expertise and optimization of resources and methodology across the enterprise. In conjunction with Government Affairs, identifies and recommends appropriate global regulatory intelligence and advocacy initiatives and for or against regulations through a variety of venues such as participation in external industry organizations, seminar presentations, development of white papers in alignment with business representation and training as well as, where appropriate, engages in the education and guidance to government and regulatory authorities.

Essential Duties and Responsibilities:

• Creates and delivers the strategy and framework to ensure best representation across internal and external forums/networks to achieve strategic goals. Provides impactful strategic advice and recommendations to drive commercial success. Influences internally and externally to ensure effective application and positioning within the regulatory environment to meet business needs.
• Participates in, or oversees participation in, regional committees to drive effective networking and representation to ensure a one voice policy.
• Develops and executes a regulatory intelligence strategy. Keeps abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may impact regulatory strategies and propose action plan.
• Oversees the development and implementation of appropriate systems, processes and standards.
• Establishes metrics to measure success and impact of policy and intelligence activities. Creates a dashboard for senior management on key regulatory and policy issues so that key activities are visible and can be discussed.
• Leads the development of a global regulatory policy and advocacy strategy. Works closely with internal partners and subject matter experts to plan and execute regulatory advocacy positions, strategies and tactics and facilitate engagement with regulators on key topics of interest. This includes to liaise closely with colleagues (R&D, Policy, etc.) leading policy activities in the external environment to ensure regulatory insights and overall alignment.
• Drives the collaboration within the company (such as Health Policy teams, Corporate Communications, etc.) to proactively understand and respond to evolving trends and ensures best position for products and access requirements regionally/globally. Creates and implements strategy with internal stakeholders to identify opportunities/threats and advocate company’s positions externally.
• Keeps Regulatory & Quality management and all internal customers, partners, and stakeholders abreast of progress and provide interim updates on ongoing activities and current initiatives. Ensures issues are escalated when needed and encourage resolution at the appropriate level.

Education:         

• B.S./B.A. in a science, engineering, or related technical field is required, Regulatory Affairs Certification a plus

Experience:       

• 10+ years  progressive experience (with master’s degree) and 12+ years (with bachelor’s degree)  with at least: 5+ years working in a Medical Device environment, 5+ years of regulatory experience and 5+ years of experience working with business stakeholders within a cross-functional matrix environment

Skills:

• Advanced knowledge of global regulatory requirements related to medical devices
• Keen ability to analyze, interpret and present complex data and technical documents with ease, and eye for strategic application
• Excellent oral communication skills and demonstrated ability to present, influence and create solid partnerships with executive leaders and regulatory agencies/trade associations
• Proven success in building, development and driving team success
• Inspiring leader that creates energy, enthusiasm and delivery of simultaneous high impact projects and results
• Facilitates development of others and leads to create a followership
• Demonstrated success in navigating through uncertainty, wielding indirect influence over teams
• Drives accountability without authority and creates confidence in regulatory excellence
• Experience in negotiating with regulatory bodies on key issues or submissions

Demonstrated experience in moving regulatory intelligence discovery into action

#medicaldevice #regulatorypolicy #regulatoryintelligence #newposition #globalregulatorypolicy #regulatorymedicaldevice #qualitymanagment #regulatoryintellgencestrategy #regulatoryaffairsrecruiter #retainedsearch

Shepherd Regulatory Search has been engaged for a newly created Remote Director (or) Senior Director Regulatory Affairs position.  This role will provide regulatory expertise from preclinical through clinical development for assigned programs.

Organization: Our client is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative treatments for severe, rare muscle disorders for which there is a significant unmet medical need.

Responsibilities:

• Oversees the writing, editing, reviewing, and compiling of documents needed for regulatory submission activities for US and global assigned products.
• Provides critical review of all documentation supporting regulatory submissions and communications.
• Prepares and submits regulatory applications, annual reports/IND amendments, and meeting requests to FDA and other regulatory agencies.
• Reviews and prepares responses to requests from regulatory authorities.
• Provides leadership for regulatory document management systems and maintains corporate regulatory files.
• Ensures regulatory milestones are met to support regulatory submission and overall business goals of the Company.
• Contribute to the development of regulatory strategies.
• Research and identify new opportunities outside of assigned work that augment the Company’s mission, vision, values, and goals
• Effectively manages and mentors regulatory staff.
• Oversees assigned external vendors and contractors responsible for providing regulatory support functions to ensure goals are achieved.
• Primary liaison with regulatory agencies and interacts with senior management to report on project or program milestones.
• Provides strategic or operational input to project team.
• Builds professional and effective external relationships crucial to the success of the organization.
• Works across internal departments to maintain credibility, trust, and support of employees and other stakeholders.
• Fully involved and responsible for all areas of communication with FDA and other government regulatory authorities.

Experience:

• Experience in Cardiology is strongly desired.
• BS/BA degree in a scientific/health sciences discipline.
• 10+ years’ experience in pharmaceutical Regulatory Affairs.
• Experience preparing submissions, regulatory documents, annual reports, amendments, and supplements.
• Proven ability to strategize with team members on the optimal way of documenting various submissions and determining the preferred plan.
• Management expertise on the timeline and process for submissions.
• Expert knowledge of regulations and guidance’s affecting routine regulatory activities and specific therapeutic areas and keeps abreast of the regulatory environment.
• In-depth knowledge of overall global drug development.
• Excellent written, interpersonal and communication skills.
• Action-oriented and committed to meeting FDA and other regulations while moving projects forward.

#remote #remotejobs #regulatoryaffairs #cardiology #directorregulatoryaffairs #seniordirectorregulatoryaffairs #newposition #lifesciences #regulatorystrategy #drugdevelopment #clinicaltrials #FDA #regulatoryaffairsrecruiter #muscledisorder #precision medicines #duchenne #musculardystrophies

JOB SUMMARY: Maintain the quality system and support outgoing product quality through the use of engineering tools and methodologies in order to support the production, design, and development of medical devices.

Responsibilities:

• Assist in the design and development of new products by contributing to risk analysis, verification and validation test plans, etc.
• Good understanding of statistical techniques, risk analysis, Gage R&R, Cpk, ANOVA, and DOE.
• Good problem-solving experience with Cause & Effect diagrams, Failure Mode Effect Analysis, Root-Cause, 5-Why, 8D.
• Approve Engineering Change Orders, review prints, and be familiar with Geometric Tolerancing.
• Maintain Quality Records.
• Perform Corrective Actions and Non-conformance assessments.
• Assist in investigating customer complaints.
• Perform internal audits as well as supplier audits.
• Support Incoming Inspection.
• Review Work Instructions, Quality Plans, FMEAs, specifications, drawings, quality systems, and analysis trends.
• Participate in and lead continual improvement projects
• Support environmental and sterilization monitoring
• Some travel required for supplier support

QUALIFICATIONS:

• Bachelor’s Degree in Mechanical or Biomedical engineering or equivalent experience.
• Very good written and verbal communication skills.
• At least 5 years of engineering experience; preferably in the medical device industry.
• CQE/CQA certification helpful but not required.
• Certified biomedical auditor is preferred.
• Familiar with FDA 21CFR820, ISO13485.
• Experience with aseptic production and/or sterilization is preferred.
• Accuracy, thoroughness, attention to detail, and legibility in completing records is essential.
• Lean and 6Sigma knowledge a plus.

#qualityengineer #medicaldevice #qualityrecords #newposition #lifesciences #engineering #biomedicalengineering# sixsigma #regulatoryaffairsrecruiter

Retained Search

Our client is a growing biopharmaceutical company focused on discovering and developing precision oncology therapeutics to address existing and emerging unmet needs to improve survival and enhance the overall well-being of cancer patients.

Role: The Vice President, Global Regulatory Affairs provides strategic and operational leadership to support product development across the organization. In this role, you will lead interactions with global regulatory agencies, coordinate with internal senior stakeholders, and manage and direct all regulatory strategic and operational initiatives.

Location: Remote

Responsibilities:

• Provide global regulatory leadership supporting global development.
• Proactively participate in the design of US and ex-US regulatory strategies for the development of precision oncology therapies.
• Direct and negotiate submissions (IND, CTA, NDA, MAA etc..) and approvals with regulatory authorities.
• Form partnerships across the Science Units to provide/facilitate provisions of the appropriate regulatory affairs advice to each area.
• Prepares and coordinates regulatory submissions (ie, clinical trial applications, formal meeting documentation, submissions, etc.); supports preparations and submission of INDs and marketing applications, as applicable.
• Supports and organizes preparations for Health Authoring meetings and teleconferences.
• Ensure adherence to current regulations associated with regulatory activities.
• Guides and executes regulatory strategy for long-term development planning, including the potential to accommodate expedited development needs.
• Provide regulatory leadership and support to project/program teams and Senior Management for all aspects of the development program (nonclinical, clinical, quality (CMC), and labeling).
• Acts as the regulatory representative on early and late phase clinical studies, ensuring regulatory compliance and guidance.
• Work within cross-functional teams to provide global regulatory expertise in support of the development, review, and approval of strategies and documents intended to enable clinical trials and marketing authorizations.
• Collaborates effectively with cross-functional teams and contract research organizations, clearly defining regulatory expectations.
• Develop and execute, or oversee global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs.
• Represent the company at appropriate regulatory and scientific conferences.

Qualifications & Experience:

• Demonstrated success in Small Molecule Oncology programs.
• Bachelor’s Degree in science-related discipline, Advanced Degree preferred.
• At least 15 years of Global Regulatory Affairs leadership experience.
• Track record of leading global regulatory activities for development program(s).
• Significant experience or equivalent of delivering positive global outcomes, across a portfolio of products, on programs varying in scientific & clinical complexity.
• Experience in precision oncology strategy is a plus.
• Extensive knowledge of ICH, FDA, EMA, HSA, PMDA, MFDS, and international regulations/guidelines.
• Must be able to solicit information, persuade others, and shape outcomes.
• Hands-on professional able to execute regulatory submissions and operations to achieve corporate goals.
• Well-versed in regulatory strategy and regulatory science writing.
• Must thrive working in a rapidly moving, innovative environment while remaining flexible, proactive, resourceful, and efficient.
• Excellent interpersonal skills and ability to develop important relationships with key stakeholders.

#remote #remotejobs #regulatoryaffairs #oncology #smallmolecule #lifesciences #globalregulatoryaffairs #regulatorystrategy #newposition #vicepresident #leadership #regulatoryaffairsrecruiter #kinase inhibitors #precisiononcology #kinase #retainedsearch

Consulting Position - Long term - Remote

This position will lead the development of a strategic integrated evidence-generation plan. Partner with GPT Evidence Generation sub-team (a multidisciplinary team), to develop/optimize the integrated strategic evidence generation initiatives across therapeutic areas, proactively anticipating any potential gaps and adjusting tactical plans to address these.

Responsibilities:

• Responsible for post-approval research excellence within the CMO.
• Supports the development of a strategy for all study types within the CMO, i.e., sponsored studies (MACs), Collaborative Research, and IIRs.
• Provides innovative thinking and scientific expertise into post-approval research programs and real-world evidence strategies.
• Supports strategic discussions for each assigned therapeutic area to identify research gaps and develop aligned strategic and tactical plans to address these gaps and works closely with GMA GPT representatives and partners responsible for executing evidence generation plan.
• Drives, builds, and maintains the strategic evidence generation plans, closely partnering with the GML, PVPA and GORE with input from multiple stakeholders (regions, SQS, etc).
• Establishes GMA framework (i.e. subteam to asset strategy team) to support evidence generation needs.
• Collaborates with cross-functional team members to define global evidentiary needs of key stakeholders (Regulatory bodies, HCPs, Patients/caregivers, Payers, and HTA bodies) to serve the evolving healthcare environment.
• Supports collaborative strategic planning and mapping of evidence-generation activities with key internal stakeholders to develop aligned and integrated generation strategies and plans.
• Provides strategic leadership and scientific direction on medical evidence activities in order to: Set standards for the utilization of medical data and maximize patients’ access to our innovative medicines.
• Participates as a functional expert on other cross-functional leadership teams.

Requirements:

• Minimum MSc degree required (preferably PhD), preferably in a health sciences-related field with 6 years of research-related experience and/or pharmaceutical industry experience.
• Experience with late-stage clinical studies, research collaborations and RWE.
• Proven track record of strong leadership, and project management and demonstrated ability to coach and mentor individuals.
• Ability to communicate and interact thoughtfully, transparently, and appropriately with a variety of stakeholders, both internal and external.
• Experience overseeing work of and mentoring other individuals with a variety of scientific and non-scientific backgrounds and training.
• Experience working in a global organization and within a matrix structure is highly desirable.

#evidencegeneration #realworldevidence #research #strategy #clinicaldevelopment #contract #remote #pharmajobs #rwe