Regulatory Manager
Core
Implement and deliver regulatory submissions and approvals for products/projects while ensuring compliance with government policies and company SOPs.
Role type
Regulatory Manager
Builds
Regulatory submissions and approvals for pharmaceutical products
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory submission management, Government agency liaison, Scientific discussion, Cross-functional collaboration, SOP compliance, Database management
Preferred skills
Knowledge of importation and local production regulations
Technologies
Regulatory databases, SOP systems
Responsibilities
Implement and deliver regulatory submissions and approvals within timelines, Establish and maintain relationships with regulatory agencies (NMPA/CDE/NIFDC), Conduct scientific discussions with internal and external functions, Maintain knowledge of scientific and regulatory requirements, Support policy and database development