Senior Manager, Global Regulatory Affairs, CMC

Brief

Description:

The Senior Manager, Regulatory Affairs Global CMC will be responsible for managing registration and CMC regulatory support for commercial and/or development projects worldwide for biological products.

• Managing the preparation and review of Module 2 and 3 CTD sections of regulatory submissions as assigned (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents) for biological products, in support of Global Regulatory Team objectives.
• Participate and support as an active member of a multi-disciplinary team to establish Regulatory CMC strategies for commercial products, late- and early-stage development programs, under the supervision of GRA-CMC leadership.
• Through the performance of risk assessments, work with GRA-CMC leadership to identify and communicate potential risks associated with strategy scenarios to the multi-disciplinary team and the Global Regulatory Team.
• Coordinate the preparation and timely submission of responses to regulatory agencies. Manage timelines to ensure approvals are timely and development objectives are met.
• May act as regulatory CMC representative at meetings with business partners and may contribute to meetings with regulatory agencies for CMC related issues.
• Ensure continued regulatory compliance of products through adherence to the change control procedures, regulatory information management procedures and completion of regulatory impact assessments for assigned commercial and development products.
• Maintenance of current regulatory product information to support product release for assigned clinical and commercial products. Verify electronic publishing of regulatory submissions.
• Identify & support continuous improvement opportunities for the GRA-CMC team and the broader GRA team.
• Ensure compliance with company policies, procedures and training expectations.

• Demonstrated understanding and strategic application of regulations and guidelines for drug lifecycle preferably for biological products.
• Solid working knowledge of CMC regulatory and ability to generate clear, well-argued positions.
• Must have experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs).
• Demonstrated understanding of FDA, EMA and ICH guidelines.
• Strong interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.

• BSc/BA with regulatory CMC or related experience.
• English language - written and verbal communication skills.

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