Director/Senior Director, Regulatory Affairs
6 days ago
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:
joel.isaac@ | +1 (980) 222 2267
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