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Regulatory Affairs Manager, CMC

4 weeks ago

Boston MA, United States Vivid Resourcing Full time

Regulatory Affairs Manager, CMC - Biologics (Phase 3 Asset | Advanced Modality) Boston area (hybrid, flexible travel) I'm currently searching for a Regulatory Affairs professional looking to take ownership of a late-stage biologic program. This is an opportunity to join a cutting-edge biotech advancing an autoimmune Phase 3 asset and play a pivotal role in shaping their global CMC regulatory strategy. The Opportunity: You’ll be the Regulatory Affairs Manager (CMC) responsible for leading all regulatory activities related to chemistry, manufacturing, and controls for a biologic program approaching BLA submission. Key Responsibilities: Develop and execute CMC regulatory strategies to support global submissions, including INDs, BLAs, and ex-US filings. Lead preparation and authoring of BLA modules for biologic products, ensuring high-quality, compliant documentation. Advise internal teams on what to include (and what not to include) in submissions, and when to seek FDA guidance to optimize outcomes. Provide strategic input on manufacturing and regulatory considerations throughout the product lifecycle. Partner closely with CMC, QA, and Supply Chain to ensure alignment with regulatory expectations. Support global regulatory initiatives beyond the US, including Europe and other major markets. Contribute regulatory insight to ongoing discussions around drug–device combinations (auto-injectors, prefilled syringes, IV infusion, etc.). What We’re Looking For: Proven experience in CMC Regulatory Affairs within biologics, must not be small-molecule only. Solid understanding of BLA authoring and strategy; prior participation in late-stage (Phase 3 or beyond) submissions. Strong grasp of IND management and lifecycle maintenance. Knowledge of advanced modalities and biologic manufacturing requirements. Comfortable working independently while collaborating cross-functionally with technical and quality teams. Experience with drug–device combination products (auto-injectors, prefilled syringes, infusion devices) is a plus. Based in the U.S. and able to travel to the Boston area a few times per quarter. Why Join: Contribute to a Phase 3 biologic on the path toward commercialization. Operate with ownership and autonomy in a lean, high-impact environment. Collaborate with talented teams in Manufacturing, Quality, and Supply while influencing global regulatory strategy. If you’re a hands-on regulatory CMC professional who enjoys driving complex biologic submissions and global strategy, I’d love to connect. Reach out directly for a confidential discussion: joel.isaac@vividresourcing.com | +1 (980) 222 2267