CSG Talent · 5 hours ago
Fractional Consultant - Regulatory Strategy
United States
Part-time
Remote
Senior LevelCSG Talent is supporting a clinical-stage biotechnology company advancing toward its initial Biologics License Application (BLA). They are seeking an experienced Regulatory Strategy Lead to provide strategic leadership and hands-on execution through BLA submission, ensuring a cohesive and inspection-ready BLA across various workstreams.
ConsultingRecruitingStaffing Agency
Hiring Manager
Shari Hulitt
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
Qualification
Required
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
Preferred
Regulatory Affairs
Biologics
Company
CSG Talent
CSG Talent is a provider of staffing and recruitment services.
Founded in 2003
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase