Regulatory Affairs Manager, CMC

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 :

Youll 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 drugdevice combinations (auto-injectors, prefilled syringes, IV infusion, etc.).

What Were Looking For :

Why Join :

If youre a hands-on regulatory CMC professional who enjoys driving complex biologic submissions and global strategy, Id love to connect.

Reach out directly for a confidential discussion :

joel.isaac@vividresourcing.com | +1 (980) 222 2267