Fractional Consultant - Regulatory Strategy

About This Role

Provide strategic leadership and hands-on execution as a Regulatory Strategy Lead for a clinical-stage biotechnology company. This fractional role will lead the preparation and coordination of BLA submission content, ensuring a complete, cohesive, and inspection-ready Biologics License Application.

Responsibilities

• Lead preparation and coordination of BLA submission content, timelines, and cross-functional inputs
• Provide detailed review and oversight of key regulatory deliverables
• Review regulatory strategy documents, FDA briefing packages, meeting materials, Module overviews and summaries
• 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

Requirements

• 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

Qualifications

• Demonstrated experience planning and coordinating a BLA submission with hands-on leadership responsibility. Prior involvement in programs progressing through FDA review, including information requests and inspections.

Nice to Have

• Regulatory Affairs
• Biologics experience