A clinical-stage biotechnology company developing a differentiated programmable mRNA platform is seeking an accomplished regulatory leader to help shape its path from early clinical development through registration.
This is a high-impact opportunity to work directly with the executive team at a critical inflection point. The mandate is not simply to manage submissions, but to work backward from approval and ensure that clinical, CMC and regulatory decisions made today support an efficient, credible path to BLA and global registration.
Responsibilities
- The successful leader will:
- Define global regulatory strategy across the lead oncology program and emerging pipeline
- Guide FDA and EMA interactions
- Shape pivotal-development, endpoint and accelerated-pathway strategy
- Advise on CMC comparability, potency, scale-up and approvability
- Identify and mitigate downstream regulatory risk early
- Build a fit-for-purpose regulatory capability as the company grows
- The ideal candidate has personally led at least one BLA, with MAA experience strongly preferred, and brings experience in oncology, complex biologics, RNA therapeutics, cell or gene therapy, cancer vaccines or another advanced modality. The company is open to a senior consultant, fractional executive, interim leader or full-time SVP-level hire.
Required Skills
- Advanced scientific or medical degree preferred
- 15+ years in biopharma regulatory affairs
- VP/SVP-level leadership experience
- Direct leadership of at least one successful BLA; MAA experience preferred
- Background in oncology and complex modalities, including nucleic acid therapeutics
- Strong FDA interaction and regulatory CMC experience
- Small biotech or consulting experience strongly preferred