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