Director / Senior Director, Regulatory Affairs - CMC

Job Description

Director / Senior Director, Regulatory Affairs - CMC (Biologics | Phase 3 Asset | Advanced Modality)

Boston area (hybrid, flexible travel)

A clinical-stage biotech developing an advanced biologic therapy in Phase 3 is seeking a Director / Senior Director of Regulatory Affairs, CMC to lead regulatory strategy and execution for a pivotal autoimmune program approaching BLA submission .

This is a high-impact leadership role suited to someone who combines deep regulatory CMC expertise with the agility to work cross-functionally in a lean biotech setting.

The Opportunity :

You’ll be the CMC regulatory lead driving global submission strategy, from IND maintenance through BLA authoring and post-approval planning. You’ll partner closely with Manufacturing, Quality, and Supply Chain teams, shaping how the company engages with regulators across major markets.

Key Responsibilities :

• Define and implement global CMC regulatory strategy for a late-stage biologic asset (Phase 3 → BLA).
• Lead preparation, authoring, and review of CMC sections for IND, BLA, and global submissions.
• Develop and execute the BLA roadmap, determining content strategy, data presentation, and agency engagement plans.
• Serve as the primary CMC regulatory point of contact with the FDA and other global agencies.
• Partner cross-functionally with Manufacturing, Quality, and Technical Operations to ensure regulatory alignment throughout process development, validation, and lifecycle management.
• Guide the organization on advanced modality expectations and best practices in biologics manufacturing.
• Contribute to future device strategy (auto-injectors, prefilled syringes, infusion / IV delivery systems), helping define regulatory pathways for combination products.
• Mentor and support junior regulatory professionals or cross-functional contributors, though this role is not directly managerial at present.

What We’re Looking For :

Why Join :

Reach out directly for a confidential discussion :

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