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.

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