Job Description

Job Description

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:

[email protected] | +1 (980) 222 2267

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