Our client is a commercial-stage medical device company dedicated to improving patient outcomes through innovative products. With a focus on excellence and quality, they are at the forefront of the medical device industry, delivering cutting-edge solutions to healthcare providers globally.

Position: The Manager of Quality Systems and Compliance will be responsible and accountable for compliance with US FDA regulatory requirements and company procedures and policies.  This position is a key interface between all functions within the company that execute activities pertaining to 21 CFR Parts 820 and 803.

Responsibilities:

• Ensure full compliance with 21 CFR 820, 21 CFR 807, 21 CFR 803, ISO 14791, FDA Guidelines
• CAPA, Risk Management, and other relevant FDA, ISO, ICH, and Industry Standards and Guidelines.
• Developing, implementing, and maintaining the Quality Manual and Quality Management System (QMS).
• Ensuring all QMS Element SOPs comply with applicable regulations.
• Manage the Document Control QMS Element, including an electronic Document Management system and compliance with FDA requirements and the Record Retention Policy.
• Managing the CAPA program.
• Manage the Quality Engineering function, ensuring proper tools and processes for administration of the QMS. 
• Managing the Internal Audit Program to prevent unfavorable FDA Inspection outcomes.
• Managing a team with responsibility for the execution of the QMS.
• Managing key aspects of the Front Room during FDA Inspections and third-party audits, such as the documents requested/reviewed log and daily transcripts.  
• Leading the Back Room during FDA Inspections and third-party audits.
• Leading the Escalation to Management Process; developing slide decks/overviews, and meeting minutes for Escalation to Management and Quality Review Board Meetings.
• Creating and presenting metrics for quarterly Quality Management Review Meetings; maintaining Quality Management Review slide decks and preparing Quality Management Review Meeting minutes.
• Managing the GMP Training QMS Element and associated IT Tool(s) used for training curriculum and training records.
• Leading Field Action Tactical Team(s).
• Conducting GMP training for all employees annually.
• Maintaining a strong collaborative partnership with cross-functional team members to facilitate a favorable compliance profile, protect patient/user safety, comply with all applicable Regulations, and meet business needs.
• Maintaining positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.

Requirements:

• Quality Management System Protégé or Mastery level knowledge and expertise
• Product Knowledge Student or Protégé level knowledge and expertise
• First-hand knowledge of Infusion Pump Technology and Software as a Medical Device.
• General Quality Assurance and Quality Systems Protégé or Mastery level knowledge and expertise.

Qualifications:

• BS degree in Engineering and/or science discipline; MS degree in Engineering and/or science discipline preferred.
• Seasoned Quality professional/leader with 5-8 years of experience, including people management, in the medical device industry, preferably in developing and maintaining Quality Management Systems for Class II or III medical devices.
• Demonstrated applied knowledge of regulatory requirements for Medical Devices (ISO 14971 and 21 CFR 820 at a minimum).
• Demonstrated leadership experience through formal and informal assignments.
• Results-orientated, multi-tasker, and quick learner; understands and responds to urgency.
• Able to successfully manage workload to timelines.
• Excellent verbal, written, and interpersonal skills.
• Applied knowledge of Microsoft Office software including Excel, Word, and PowerPoint

#qms #qualitymanagementsystems #compliance #medicaldevice #qualityassurance #infusionpumps #Protégé #newjobalert #capa

Retained Search - Hybrid Position Boston (or) Pennsylvania

Role: Director of Global Regulatory Affairs CMC, will provide regulatory leadership for CMC matters related to T-cell therapies for the treatment of cancer. You will work cross-functionally with various teams, including R&D, clinical development, manufacturing, and quality assurance, to develop and execute regulatory strategies that support these therapies' development, registration, and life-cycle management.

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

Key Responsibilities:

• Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.
• Acts as point of contact to cross-functional teams on regulatory CMC project issues. Ensures project teams, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating professionally and on time.
• 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.
• Plans, execute, and manages regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, and responses to queries.
• Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
• Ability to remain current on CMC regulatory intelligence, including guidelines and regulatory trends, and to drive and implement strategic policy decisions.
• Evaluate change proposals for global regulatory impact and plan global amendments.

Qualifications & Experience:

• Experience in cell and gene therapy required.
• Experience with BLAs/NDAs/MAAs required.
• Bachelor's Degree required; advanced Degree preferred.
• Minimum of 10 years of pharmaceutical/biotech experience, including 5 years of Global Regulatory Affairs CMC experience.
• Experience as a RA CMC product lead.
• Experience with pharmaceutical development of drug substance or drug products, analytical characterization, process scale-ups, and or regulatory registration of products.
• Understanding and proven ability to provide strategic guidance to drug development, registration, and post- market support teams.
• Provides regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/ specific regulatory guidance.
• Proven experience with filing and maintenance of regulatory dossiers (CTAs, INDs, IMPDs, BLAs/MAAs).
• Proven ability to liaise with Regulatory Agencies, having led successful Agency interactions related to CMC submissions and product development meetings; international experience preferred.
• Knowledge of relevant domestic and global regulations and guidance.

#cmc #regulatorycmc #regulatoryaffairs #celltherapy #cancerimmunotherapy #oncology #car-t #newposition #hybrid #director

Retained Search

Our client is seeking an experienced and strategic leader to join their team as the Vice President of Quality Assurance & Compliance. In this critical role, you will be instrumental in ensuring the highest standards of quality and regulatory compliance across the organization. Reporting directly to the executive leadership team, you will lead the Quality and Regulatory Assurance and Compliance efforts, driving the implementation and adherence to the Quality Management System (QMS) and driving product quality performance to meet or exceed industry standards.

Responsibilities:

• Lead a team of the following disciplines: Product QA, Software QA, Quality Systems, and Post Market Surveillance.
• Responsible for maintaining compliance and the continuous improvement in the Quality & Regulatory Management System regarding ISO 9001, ISO 13485, ISO 14001, IEC 62304, EMS, CMDR SOR/98-282, MDD 93/42EEC and MDR 2017/745, and 21 CFR Part 820 and further regulatory requirements which apply to the product portfolio.
• Serve as the point of contact with the Notified Bodies.
• Serve as the primary contact for FDA, TÜV, regulatory, and third-party audits and inspections and/or preparation as necessary.
• Ensures that the cross-functional organization is aligned and prepared for audits and inspections.
• Defines Quality & Regulatory Management goals and ensures alignment with other relevant business goals.
• Analyzes and reviews quality management goals and breaks down corresponding goals for the relevant product quality targets.
• Drives the achievement of the agreed-upon targets to achieve business targets in both Quality and Process Performance.
• Refines and fosters a set of necessary quality statistics and methodologies. Responsible for CAPA, PQB, and QMS Boards.
• Serves as the Management Representative for ISO 9001, ISO 13485, FDA, ISO 14001 and as Person Responsible for Regulatory Compliance.
• Also responsible for providing periodic reporting on a local and global level.
• Provide leadership and guidance to and oversight of internal and external resources to ensure the company remains in compliance with applicable and phase-appropriate quality-related standards, regulations, and cGMP practices.
• Establish and maintain the quality & regulatory systems, including cGMP compliance, document control, training, CAPA, quality metrics, internal audits, management controls, software quality, and post-market surveillance.
• Serves as a member of the Management Team, provides information to management that could impact QA compliance, and promotes awareness of customer requirements and feedback to the management team.
• Manage Department budget and resources to address strategic needs within the Quality & Regulatory department, including hiring decisions, talent management, and mentoring development.
• Responsible for the implementation of an Integrated Management System.
• Ensure effective Quality System implementation within the CFTs and Product Steering Boards. Educates responsible organizations in all commercial and quality/process-relevant topics.
• Drives Software Quality Assurance (SWQA) and Compliance for new developments and legacy products. Promotes awareness of customer requirements, monitors quality performance, and communicates customer quality issues and resolution thereof.
• Assures product quality by involvement in the development process.

Requirements:

• Bachelor’s Degree in a scientific discipline, life sciences, biomedical or other engineering science - Master’s or a PhD (desired).
• Quality and Environmental (knowledge of current ISO 9001, ISO 13485, IEC 62304, ISO 14001).
• CMDR SOR/98-282, MDD 93/42/EEC and MDR 2017/745, 21 CFR Part 820, where applicable.
• A formal Six Sigma qualification is preferred.
• Minimum of 15 year’s experience in either a quality or regulatory role in the medical or safety device industry with at least 7 years in a management role.
• Ability to develop, implement, and manage an integrated QMS; to lead multi-level and multi-discipline work teams to develop, implement, and manage processes/business systems.
• Prefered experience in managing both quality and regulatory.
• Strong influencing skills at all levels to lead the decision-making process with executive management, peers, and subordinates.
• Sound people management and change management experience.
• Strong interpersonal and communication skills and the ability to persuade and influence others at all levels within the company.
• Capacity for analytical thought
• Proven track record in applicable disciplines of ISO 9001, ISO 13485, IEC 62304, US FDA and MDD compliant Quality Management and ISO 14001 Environmental Management systems and demonstrated success in developing a proactive organization in a compliant environment.

#medicaldevice #qualityassurance #compliance #qualitymanagment #regulatorycompliance #qualitysystems #qms #leadership #executivesearch #regulatoryaffairsrecruiter

Shepherd Regulatory Search has been engaged for a newly created Remote 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. 

Location: Remote

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 augments 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.
• Able to handle changing priorities and multidisciplinary tasks.

#remote #remotejobs #regulatoryaffairs #cardiology #directorregulatoryaffairs #seniordirectorregulatoryaffairs #newposition #lifesciences #regulatorystrategy #drugdevelopment #clinicaltrials #FDA #regulatoryaffairsrecruiter

Retained Search - Hybrid Position

Position Overview: Responsible for overseeing and managing the quality function and all aspects of quality. Establish and maintain a robust quality management system, processes, and procedures to ensure compliance with applicable health authority regulations, guidelines, and standards. Represent quality on the management board/leadership team. Serve as the primary point of contact for quality-related matters during regulatory inspections, audits, and customer inquiries.

Responsibilities:

• Develop and implement a comprehensive quality strategy and roadmap aligned with business objectives and regulatory standards.
• Develop and implement the Quality Goals and Objectives.
• Develop the quality budget.
• Collaborate closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain, to ensure seamless integration of quality standards throughout the product life cycle.
• Oversee the supplier quality and third-party oversight program, including audits to identify potential quality issues, deviations, or non-conformities, and implement appropriate corrective and preventive actions.
• Stay abreast of evolving regulatory requirements and industry trends to proactively identify process improvement and innovation opportunities.
• Foster a quality and continuous improvement culture by organizing training programs, workshops, and knowledge-sharing initiatives.
• Lead management review. Serve as the management representative. Chair the Quality Board; holds the responsibility for market actions.
• Responsible for Post Market and Complaint Vigilance.
• Responsible for the Quality Aspect of Design Control.
• Lead continuous improvement initiatives, implement digital quality strategies, and drive simplification of processes.
• Driving quality culture.
• Responsible for company-wide training.
• Ensure quality strategy is aligned with business needs and integrated into company goals and objectives.
• Monitor quality skills and capabilities as the business evolves.

Requirements:

• Bachelor’s degree in science or engineering with 15+ years of experience in medical devices or Master’s degree with 12+ years of experience in medical devices.
• Deep working knowledge of quality systems and compliance.
• Demonstrated success in leading and managing a team of quality assurance professionals, providing guidance, coaching, and performance evaluations.
• Experience hosting and facilitating regulatory inspections and skilled in interacting with government officials.
• Strong technical judgment and advanced leadership skills.
• Strong risk management skills.

#medicaldevice #qualityassurance #leadership #training #newposition #strategy #riskmangment #qualityauditing #medicaldevicequality #executivesearch

Retained Search - Hybrid Position

Position Overview: The Vice President of Regulatory Affairs will be responsible for developing and leading the Regulatory strategy while providing strategic and operational leadership to the organization. In this role, you will lead and manage a team of regulatory affairs professionals, providing guidance, coaching, and performance evaluations.

Responsibilities:

• Development of Regulatory Strategies that optimize product development and registration.  
• Lifecycle management of new and marketed products, taking into consideration current and proposed changes in regulatory requirements and standards.
• Lead and manage a team of regulatory affairs professionals, providing guidance, coaching, and performance evaluations.
• Effectively communicate the regulatory strategy, risks, mitigations, and overall plans to the management teams.
• Advises project teams regarding the development and implementation of regulatory strategy. Maintains awareness of the changing regulatory landscape and advises the team on changes that could impact future development.
• Accountable for ensuring regulatory compliance of all external materials.
• Maintain current knowledge of the global requirements and changes to applicable laws, regulations, and industry standards, and assist in disseminating this information to the appropriate individuals within the company.
• Interpret new and existing regulatory requirements related to the products and initiate actions to assure compliance with these regulations.
• Support where required internal and external audits/inspections.
• Manage the regulatory budget.
• Works with the management team to ensure all company regulatory programs achieve internal expectations.
• Ensure regulatory strategy is aligned with business needs and integrated into company goals and objectives.
• Monitor regulatory skills and capabilities as the business evolves.

Requirements:

• A minimum of 15 years of experience in a Regulatory leadership role within Class II medical devices.
• Bachelor’s degree in science or engineering.
• Experience with electro-mechanical medical devices.
• Experience with FDA remediation.
• Demonstrated track record in securing product approvals.
• Have excellent communication and presentation skills with the ability to influence and demonstrate a track record of accomplishment in presenting, interacting, and building effective relationships internally and externally.
• Expert knowledge of the FDA regulations and base knowledge of global markets.
• A detailed knowledge of Quality Management Systems and their requirements for regulatory purposes - 21 CFR 807, QSR, ISO 13485 Medical devices.
• An understanding of ISO 14971 Medical devices and the application of risk management to medical devices.

#medicaldevice #regulatoryaffairs #regualtorystrategy #medicaldeviceregulatoryaffairs #executivesearch #retained #hybrid #electromechanical #newposition #regulatoryaffairsrecruiter

Retained Search

Position Summary: The Director RA/QA is responsible for building, advancing, and sustaining the Quality Management System (QMS) and ensuring that it meets applicable state, federal, and international regulations and business quality standards. Additionally, this role is responsible for establishing a regulatory strategy and maintaining compliance with applicable regulatory requirements. The Director RA/QA will be supported by consulting Subject Matter Experts (SME) for both Regulatory Affairs and Quality Assurance.

Responsibilities:

• Lead maintenance and advancement of the company QMS including sustaining its certification to ISO 13485.
• Establish and maintain compliance with Class I/II medical device regulatory requirements for the US and Canada through Regulatory strategy and ongoing reviews of product and regulatory guidance changes.
• Establish and maintain compliance with Data Privacy and Security regulatory requirements.
• Serve as the Organization’s Management Representative (MR), the point of contact for all quality and regulatory communication with applicable agencies and bodies.
• Process owner for all QMS processes.
• Responsible for working with Engineering and Operations to advance the Design Control systems and develop validation/qualification protocols and Risk Management files that meet applicable Regulations, Guidance, and Procedures.
• Conduct internal audits and coordinate and manage external ISO/Regulatory audit schedules, correspondence, and closing of findings.
• Effective and timely review of change orders and technical documentation.
• Review, audit, and approve Device Master Records, Design History Files, and ensure that the records and files are updated.
• Responsible for managing RA/QA department, including internal and external resources and partners.
• Responsible for reviewing and establishing the company quality goals and objectives each year and leading Management Reviews.
• Establish and maintain Key Process Indicators.

Requirements:

• BS in Engineering, Regulatory Affairs, Quality Engineering, or equivalent technical degree.
• 5+ years of medical device management experience.
• Demonstrated aptitude in leading teams and organizations that comply with 21 CFR 200 et al, 21 CFR 820, 21 CFR 830, SOR/98-282, and ISO13485.
• Regulatory compliance related to medical device industry, including experience submitting medical device applications for US and Canada.
• Knowledge of Data Privacy and Security Regulations and Standards.
• Proven experience working directly with domestic and foreign regulatory authorities.
• Ability to analyze and interpret standards and government guidance and regulation documents and translate into internal strategies and policies.
• Ability to write standard operating procedures, work instructions, specifications, and technical reports.
• Ability to effectively communicate company status, goals, and initiatives throughout the organization.
• Demonstrated success in leading teams and departments, including external partners.
• Ability to effectively communicate company status, goals, and initiatives throughout the organization.
• A hands-on leader willing to work side by side with a small, agile team.
• Certified Quality Auditor (CQA) - Regulatory Affairs Certification (RAC) - Six Sigma Certification -Experience with Veeva Software preferred.
• Experience with all applications in Microsoft Office 365.

#medicaldevice #qualityassurance #regulatorystrategy #certifiedqualityauditor #qualitymanagmentsystems #iso13485 #designcontrol #managment #qms #audit

Position Overview: The Complaint Vigilance Director will lead the strategic direction and ensure the success of the Complaint Handling, MDR, and post-market reporting programs. In this role, you will be responsible for managing the Vigilance Team. Responsible for team goal setting, performance assessments, and day-to-day people management. Ensures complaints management procedures are optimized and that the vigilance team responds to and resolves complaints within a timely fashion while conforming to the correct standards and procedures. 

Responsibilities:

• The primary interface to other department heads and upper management for complaint-related topics and trends.
• Execute complaint vigilance in conformance to current standards and procedures, using applicable system application tools in accordance with 21CFR820 / 21CFR803 and other regulations as required. 
• Oversee the triage assessment of complaints and assess initial risk and severity; Oversee the receipt, evaluation, investigation, and closure of complaints, including device malfunctions.
• Makes critical decisions for the Complaint Handling Unit (CHU).
• Work with all product/manufacturing/research & development/quality teams to ensure timely, accurate, and complete investigations of product complaints and timely closures.
• Review reports of complaint trends.
• Oversee the assessment of complaints for MDR reportability to the FDA.
• Ensure initial and follow-up reports are submitted to Regulatory Agencies within the required timelines.
• Ensure complaints are classified correctly and that all supporting data are adequately documented and attached to the complaint file.
• Ensure procedures meet current and evolving requirements.
• Review metrics on process timeliness and effectiveness.
• Oversee post-market surveillance activities.
• Review and approve Complaint Vigilance Reports (i.e. quarterly trending, monthly complaint records) in a timely manner.
• Conduct annual complaint training for all employees, including field sales, on the requirements to report complaints in a timely manner.

Requirements:

• Bachelor’s degree in science or engineering with 10+ years of experience or Master’s Degree with 7+ years’ experience in medical devices.
• Medical Device experience required.
• Extensive experience and deep working knowledge of complaint vigilance and MDR reporting. 
• Experienced in regulatory inspections and skilled in interacting with government officials.
• Experience with 21CFR820 / 21CFR803 and other regulations as required.
• Experience with post-market surveillance activities.

#medicaldevice #complaintmanagment #complaintinvestigations #mdr #reporting #newpoisition #hybrid #boston #executivesearch #director

My client seeks a highly skilled and experienced Principal Regulatory Affairs and Quality Medical Device Professional. In this role, as a pivotal member of the team, you would lead Regulatory Strategy and Compliance for a diverse range of medical devices. Working closely with cross-functional teams to ensure products meet global regulatory standards, providing safe and effective solutions for healthcare providers and patients. If you are passionate about ensuring the safety and effectiveness of medical devices, this is the perfect opportunity to impact healthcare worldwide positively.

Position: The initial focus of this role will be to ensure that regulatory files are compliant for 510K, de Novo, and PMA submissions; identify gaps between 21 CFR Parts 800-1299 and EU MDR requirements, and ensure regulatory files are compliant with US regulatory requirements.

Responsibilities:

• Develop and execute US Regulatory Strategies for product development and submissions, ensuring alignment with global regulations and standards.
• Maintain compliance with relevant regulations, standards, and guidelines throughout the product lifecycle.
• Assist in preparing responses to US regulatory authorities' questions within assigned timelines.
• Recommends changes for clinical protocol for US regulatory compliance.
• Recommends strategies for earliest possible approvals of clinical trials applications in US.
• Assist in preparing clinical trial site ethics review board/FDA applications for investigational device trial(s). Review interim or final reports for trial site ethics boards/FDA as required.
• Conduct risk assessments and collaborate with product development teams to mitigate potential regulatory risks.
• Ensure product labeling and packaging comply with US regulatory requirements.
• Act as a liaison between the Company and FDA, respond to inquiries and requests for information.
• Performs coordination and preparation of document packages for audits and inspections from all areas of the company, providing regulatory input to minimize the potential for findings of non-compliance.
• Provide guidance and training to cross-functional teams on regulatory requirements and updates to raise US requirements knowledge within the Company.
• Stay abreast of regulatory procedures and changes in regulations, standards, and industry trends to anticipate and adapt to evolving requirements.

Qualifications:

• Experience with 510(k) submissions and PMA applications required.
• Minimum of ten years of regulatory affairs experience in the medical device industry required.
• Bachelor's degree in a relevant scientific or engineering field required (advanced degree preferred).
• Strong knowledge of FDA regulations (21 CFR 812, 814 and 820), ISO standards (ISO 13485: 2016, ISO 14971: 2019).
• Excellent knowledge of the applicable medical device regulations in various countries--including current developments (EU-MDR) is an advantage.
• Ability to work collaboratively in a cross-functional team environment.
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational abilities.
• Independent, reliable, and communicative personality for delivering high-quality.

#regulatoryaffairs #medicaldevice #510(k) #PMA #director #quality #regulatoryaffairsmedicaldevice #newjobalert #globalregulatoryaffairs #executivesearch

Hybrid Position: Philadelphia (or) Boston

My client is a late-stage global biotechnology company developing first-in-class T-cell-based cancer immunotherapies. They are seeking an Associate Director of Regulatory Affairs to lead, develop, and execute global regulatory strategies for assigned programs.

Position: Reporting directly to the Vice President of Regulatory Affairs, you will serve as the primary liaison to regulatory agencies and lead submission activities. The Associate Director of Regulatory Affairs will be responsible for developing, implementing, and leading global regulatory strategies designed to facilitate the success of our products across their entire lifecycle.

Responsibilities:

• Leads and defines the global regulatory strategy and executes regulatory strategies.
• Preparation and supervision of preparation of regulatory submissions, including INDs, CTAs, GMOs, IDEs, amendments, annual reports, meeting briefing documents, responses to regulatory agency information requests, marketing authorization applications, and other regulatory submissions, as applicable.
• Serves as the primary liaison with FDA and other regulatory agencies throughout the development of projects, including support for regulatory agency meetings and teleconferences.
• Identify and assess existing and new regulations, guidance documents, international standards, or consensus standards; provide interpretive guidance and ensure applicable implementation into development planning and execution.
• Ensures that all regulatory activities and documents submitted to regulatory agencies are evaluated to ensure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance to facilitate agency review and acceptance.
• Represents Global Regulatory Affairs as the primary contact on regulatory aspects of the projects and as a member of the cross-functional project team, providing regulatory guidance/strategy/perspective in team meetings and presentations at senior leadership governance meetings.
• Participate in due diligence activities on potential licensing, acquisition, or collaboration opportunities.
• Reviews and establishes standard operating procedures (SOPs) and global regulatory affairs processes.
• Manages vendors and clinical research organizations (CROs) performing regulatory activities on behalf of the company.
• Ensure regulatory documentation is maintained appropriately.

Qualifications & Experience:

• Bachelor’s Degree required. Advanced Degree preferred.
• At least 6 years of Global Regulatory Affairs experience.
• Must have Cell or Gene Therapy experience.
• Must have experience filing regulatory dossiers (CTAs, INDs, IMPDs, IDEs)
• Oncology experience is strongly preferred.
• Experience with BLAs/NDAs/MAAs preferred.
• Solid working knowledge of relevant domestic and global regulations and guidance.

#lifesciences #newjobalert #regulatoryaffairs #celltherapy #oncology #biotech #executivesearch #regulatorystrategy #drugdevelopment #regulatoryaffairsrecruiter

Our client is a commercial-stage pharmaceutical company committed to developing and commercializing therapeutics to help improve patients' lives with severe eye disorders. With approved products and a robust pipeline, this is the perfect time to join this growing team.

Position: In this high visibility role, you will report directly to the Chief Regulatory Officer. The Director of Regulatory Affairs Strategy will be responsible, in alignment with the CRO, for assisting in designing regulatory strategies during the development and life-cycle management of assigned programs. In this role, you will act as the primary regulatory liaison with the US FDA and work closely with the Global Clinical Research Organization and ex-US consulting firms to coordinate the execution of established regulatory submission plans.

Responsibilities:

• Assists the Chief Regulatory Officer (CRO) in designing and implementing regulatory strategy plans for assigned products/projects, form development, and throughout the life cycle of the dossier/product.
• Working closely and collaboratively with Regulatory Operations and Regulatory CMC, this is a 'hands-on' position where an individual must be versatile and capable of managing the operational workload and strategy execution.
• Interfaces directly with the US FDA and acts as primary liaison.
• Authoring health authority responses alongside subject matter experts and submission deliverables.
• Manage the routine maintenance of open regulatory applications, emphasizing high-quality, timely submissions to Regulatory Agencies, submission activities initial IND, NDA,
• Coordinates with Regulatory Operations and Regulatory CMC.
• Works closely with CRO to prepare and facilitate informal and formal regulatory meetings aligned with established regulatory and development strategies.
• Participates actively and assists CRO in the Advertising and Promotional Review and submission (FDA 2253) process.
• Works with functional groups to ensure documents adequately support the established regulatory strategies.
• With minimal supervision, manage routine development and post-approval regulatory activities.
• Maintains working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
• Archives and maintains regulatory submissions, correspondence, and other regulatory documents in compliance with regulatory requirements and SOPs.

Qualifications:

• BA/BS degree in life sciences discipline, Master of Sciences in Regulatory Affairs is highly desirable.
• At least 5-7 years of pharmaceutical industry experience, of which at least 4 years of Regulatory Affairs strategy drug development experience.
• Experience and knowledge in preparation of INDs, NDAs, and supportive amendments or supplements.
• Working knowledge of eCTD elements and structure, ICH standards, and submission requirements.
• Experience with small molecules and drug-led-device combination products preferred.
• Ophthalmic experience preferred.
• Experience in Clinical Trial Authorization Applications in Canada, EU, and other regions/countries is preferred.
• Experience with eCTD (US and ex-US) and using Regulatory Information Management System preferred.
• Strong communication and regulatory writing skills.
• Proficient in MS Word and Adobe Acrobat Pro applications and use of eCTD templates.

#hybrid #newjobalert #lifesciences #pharmaceutical #biotech #regulatoryaffairs #drugdevelopment #ophthalmic #executivesearch #regulatoryaffairsrecruiter

As a Senior Design Assurance Engineer for medical laser products, you will be responsible for ensuring that the products meet regulatory and quality requirements throughout the design and development process. This involves collaborating with cross-functional teams to ensure that the design outputs are verified and validated against user needs and regulatory requirements.

Responsibilities:

• Conduct product design control activities for new and sustaining product development efforts.
• Support risk analysis activities, including design and process FMEA.
• Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities.
• Support Design Engineering in the creation of Design History and Technical Files.
• Interact with third-party test houses that conduct compliance testing.
• Assist the regulatory department with FDA, CE, and other regulatory submissions.
• Perform all other essential duties as assigned.

Requirements:

• Bachelor’s Degree in scientific or engineering field; electrical engineering is preferred.
• 3-5 years of experience with engineering and development of Class II electro-mechanical medical devices.​
• Knowledge of Design Controls and Risk Management practices, regulations, and standards, such as FDA QSR’s, ISO 13485, ISO 14971, IEC 60601, 60825, 62366, and 62304 is preferred.
• Hands-on experience with Programmable Electro-mechanical Medical Systems (PEMS), New Product Development (NPD), and New Product Introduction (NPI).
• Supporting medical device compliance testing (e.g. EMC, EMI, IEC) with external test houses, such as TUV an Intertek.
• Maintenance of technical design documentation, such as design specifications, verification/validation protocols, and DFMEA/PFMEA.
• Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power, and sample size determinations, etc.), including statistical software tools, such as Minitab, is preferred.
• Experience with lasers and optical technologies is desired but not necessary.
• Strong working knowledge of Microsoft Word and Excel.

#newposition #dessignassurance #quality #medicaldevice #medicallaser #electromechanical #iso13485 #electromechanicaldesign #regulatoryaffairsrecruiter #newproductdevelopment #lifesciences #qualityassurance #classII #npi #npd #pems

Shepherd Regulatory Search has been engaged for a newly created Remote Associate 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. 

Primary Responsibilities:

• Oversees the writing, editing, reviewing, and compiling of 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.
• 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 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.

#remote #regulatoryaffairs #newposition #raredisease #muscledisorders #lifesciences #biotech #pharma #drugdevelopment #regulatorysubmissions #regulatoryaffairsrecruiter #clinicaldevelopment #associatedirectorregulatoryaffairs #musculardystrophy 

We have a newly created FTE opportunity for an Associate Director of Regulatory CMC. In this role, you will provide CMC Regulatory guidance and strategic support to clients and teams, ensuring that regulatory submissions and documentation are accurate and compliant with relevant regulations, guidelines, and industry standards.

Organization: My client is 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 consultant team with an experienced scientific professional with strong interpersonal skills.

Responsibilities:

• Author/compile CMC sections of regulatory submissions
• Research and apply current regulatory expectations relating to manufacturing, analytical methods, stability, and supply chain controls.
• Assist in managing CMC development projects.
• Assist in the selection process for contract manufacturing/laboratory vendors to support client programs.
• Assist in the creation and execution of phase-appropriate Pharmaceutical Quality Management Systems to comply with applicable cGMPs.
• Review, assess, and/or analyze CMC development data/information to draw conclusions and/or formulate strategies to progress product development.
• Process, publish, and review electronic regulatory submissions in eCTD format.
• Perform quality control review of technical aspects of regulatory submissions and critical review of submission components to ensure technical completeness of submissions.

Requirements:

• Bachelor’s degree, preferably in a scientific field (e.g., biology, chemistry, biochemistry, etc.). An advanced degree is desirable.
• A minimum of 10 years in the pharmaceutical/biotechnology industry and consulting with at least 5 years in CMC Regulatory Affairs.
• Experience in writing and reviewing CMC regulatory documents to support global filings such as IND/IMPD, BLA, MAA.
• Good understanding and experience with current GMPs and regulatory expectations for investigational and commercial products.
• Ability to interpret GMP-related matters and review CMC aspect of regulatory documents.
• Experience with CTD format and content.
• Ability to independently plan, execute and manage regulatory submissions for assigned products in clinical development, during global registrations, and post-approval life cycle activities.
• Ability to work independently and within a group setting and to interact effectively with different functional areas.
• Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
• Strong computer skills using MS Word, Excel, and PowerPoint.

#cmc #regualtorycmc #lifesciences #biotech #pharma #newposition #drugdevelopment #regulatoryaffairscontracting #regulatoryaffairsconsulting #clinicaldevelopment #regulatorysubmissions #cmcsections #regulatoryaffairsrecruiter

Consulting Position - Remote

We have a newly created long-term CMC Regulatory & Quality consulting position. In this role, you will provide CMC Regulatory guidance and strategic support to clients and teams, ensuring that regulatory submissions and documentation are accurate and compliant with relevant regulations, guidelines, and industry standards.

Responsibilities:

• Author/compile CMC sections of regulatory submissions
• Research and apply current regulatory expectations relating to manufacturing, analytical methods, stability, and supply chain controls.
• Assist in managing CMC development projects.
• Assist in the preparation of study protocols/reports, specifications, analytical methods, batch records, and other technical documents supporting CMC development.
• Assist in the selection process for contract manufacturing/laboratory vendors to support client programs.
• Assist in the creation and execution of phase-appropriate Pharmaceutical Quality Management Systems to comply with applicable cGMPs.
• Review, assess, and/or analyze CMC development data/information to draw conclusions and/or formulate strategies to progress product development.
• Process, publish, and review electronic regulatory submissions in eCTD format.
• Perform quality control review of technical aspects of regulatory submissions and critical review of submission components to ensure technical completeness of submissions.
• Provide support to colleagues in the other practice areas, including clinical, nonclinical, regulatory, and quality.

Requirements:

• Bachelor’s degree, preferably in a scientific field (e.g., biology, chemistry, biochemistry, etc.). An advanced degree is desirable.
• A minimum of 5 years in the pharmaceutical/biotechnology industry and consulting with at least 3 years in CMC Regulatory Affairs.
• Good understanding and experience with current GMPs and regulatory expectations for investigational and commercial products.
• Experience with CTD format and content.
• Ability to work independently and within a group setting and to interact effectively with different functional areas.
• Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
• Strong computer skills using MS Word, Excel, and PowerPoint.

#remote #contractor #contracting #cmcconsultant #regulatorycmc #cmcdevelopment #qualityconsultant #lifesciences #biotech #pharma #medicaldevice #qms #qualitymanagementsystems #cgmp #gmp #regulatorysubmissions #regulatoryaffairsrecruiter #manufacturing #analyticalmethods