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:

• 10+ years of Regulatory Affairs experience , including direct CMC responsibility within biologics.
• Proven track record supporting late-stage submissions (Phase 3 - BLA) and global regulatory filings.
• Strong understanding of manufacturing and analytical CMC considerations for biologics.
• Ability to build and execute global regulatory strategies across the U.S., EU, and other key regions.
• Experience in advanced modalities or drug–device combinations highly preferred.
• Collaborative communicator who can influence senior stakeholders while remaining detail-focused.
• U.S.-based, with ability to travel to the Boston area a few times per quarter.

Why Join:

• Opportunity to own regulatory strategy for a pivotal Phase 3 biologic asset.
• Work within a nimble, science-driven biotech backed by strong scientific and operational teams.
• Operate with autonomy and visibility across the full product lifecycle, from late clinical stage through potential licensure.

Reach out directly for a confidential discussion:

[email protected] | +1 (980) 222 2267

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