Fractional Consultant - Regulatory Strategy
Overview
We are supporting a clinical-stage biotechnology company advancing toward its initial Biologics License Application (BLA). As the program enters late-stage development, the company is seeking an experienced Regulatory Strategy Lead (Contract) to provide strategic leadership and hands-on execution through BLA submission.
This role is intentionally fractional but deeply embedded. The successful consultant will operate at both the strategic and executional level, ensuring a complete, cohesive, and inspection-ready BLA across Clinical, CMC, Quality, and Regulatory workstreams.
Key Responsibilities
- Lead preparation and coordination of BLA submission content, timelines, and cross-functional inputs
Provide detailed review and oversight of key regulatory deliverables, including:
Regulatory strategy documents
FDA briefing packages and meeting materials
Module overviews and summaries, as applicable
Ensure alignment across Clinical, CMC, Quality, and external partners (CROs, consultants, regulatory publishing vendors)
Support inspection readiness and responses to information requests during review
Provide strategic guidance through submission and into the initial FDA review period
Required Experience
Demonstrated experience planning and coordinating a BLA submission with hands-on leadership responsibility
Strong understanding of FDA regulatory requirements for biologics
Proven ability to operate effectively in a lean, fast-moving biotech environment
Experience managing cross-functional timelines and dependencies across Clinical, CMC, and Quality
- Prior involvement in programs progressing through FDA review, including information requests and inspections
Comfort working directly with senior leadership and external regulatory advisors
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