Senior Manager, Regulatory Affairs US Lead
Core
Leading US regulatory strategies and activities for complex rare disease products to achieve successful FDA registration and lifecycle management.
Role type
Senior Manager, Regulatory Affairs (US Lead)
Builds
Regulatory submissions (INDs, BLAs/NDAs, orphan drug designations) and lifecycle management for rare disease assets.
Domain
Pharmaceuticals / Rare Diseases / US Regulatory Affairs
Required skills
US regulatory strategy, regulatory submission management, FDA interaction, GxP compliance, project leadership, cross-functional collaboration, risk assessment, regulatory trend analysis
Preferred skills
Postgraduate degree (MSc, PharmD, PhD), experience with Veeva, additional languages
Technologies
Microsoft 365, Veeva
Responsibilities
Develop and implement US regulatory strategies for assigned products; manage and execute regulatory submissions (INDs, BLAs/NDAs, orphan drug designations); represent the company as the point of contact with the US FDA; oversee operational regulatory authorization activities; support internal governance and inspection/audit support; collaborate with cross-functional teams on business deliverables; stay updated on emerging regulations and guidances.
Seniority
Senior Manager, hands-on IC with leadership responsibilities