Senior Vice President of Regulatory Sciences

Responsibilities

• 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

Requirements

• 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