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. Essential Functions 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. Required Knowledge, Skills, and Abilities 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. Required/Preferred Education and Licenses BSc/BA with regulatory CMC or related experience. English language - written and verbal communication skills.

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• J-18808-Ljbffr Jazz Pharmaceuticals