Sr. Director, Regulatory Affairs

📋 Description

• Lead CMC regulatory strategy for IND/CTA, NDA/MAA and post-approval filings.
• Partner with CMC, Quality, Regulatory Ops and cross-functional teams for timely submissions.
• Advise on CMC risks, changes, health authority interactions, and submission plans.
• Coordinate responses to health authority requests; ensure document conformance.
• Mentor junior staff; oversee vendors and assignments; provide feedback.
• Apply AI-enabled tools to improve efficiency and consistency of regulatory deliverables.

🎯 Requirements

• BA/BS in Chemistry, Pharmaceutical Sciences, or Life Sciences; advanced degree preferred.
• Extensive Regulatory Affairs CMC experience, including NDA/MAA submissions.
• Led complex global submissions with ROW (MENA, LATAM, APAC).
• Strong knowledge of global health authority regs, CMC development and Quality docs.
• Lead through influence in a matrixed org; cross-functional collaboration.
• Mentoring/coaching experience; prior staff management preferred.
• Experience applying AI-enabled or digital tools to regulatory workflows.
• Ability to travel ~10–20%.

🎁 Benefits

• Market-leading compensation
• 401(k) with employer match
• Employee Stock Purchase Program (ESPP)
• Pre-tax commuter benefits
• Hybrid work model with flexibility
• Comprehensive medical, dental, and vision coverage