Sr Manager, Global Regulatory Affairs, WCH
Core
Sr Manager supporting global regulatory strategy and execution for assigned programs, managing submissions across multiple regions and serving as a key contact for external partners.
Role type
Senior Manager, Global Regulatory Affairs
Builds
Regulatory submissions (INDs, CTAs, NDAs/BLAs) and labeling strategies for biopharmaceutical programs
Domain
Biotechnology / Pharmaceutical Regulatory Affairs
Required skills
Global regulatory requirements knowledge, multi-region submission management, health authority query resolution, regulatory systems proficiency (Veeva Vault, Docubridge, CTIS), project management, cross-functional collaboration
Preferred skills
CTA management, BLA support
Technologies
Veeva Vault, Docubridge, CTIS, GRIT
Responsibilities
Collaborate with Global Regulatory Lead on strategy and execution; Lead or support review of regulatory submission packages; Manage health authority query responses; Coordinate with Regulatory Operations and CROs; Provide guidance on US labeling precedence; Maintain regulatory systems; Serve as backup for team members
Seniority
Senior, hands-on Manager