(Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing
Core
Develop and execute global regulatory strategies for assigned R&D programs, ensuring compliance and managing submissions.
Role type
Senior Manager, CMC Regulatory Affairs
Builds
Global regulatory strategies and compliant submission documents for assigned programs
Domain
Pharmaceutical R&D, Regulatory Affairs
Required skills
Regulatory strategy development, CMC requirements expertise, Health authority negotiation, Project team leadership, Regulatory submission management, Risk mitigation
Preferred skills
Cross-functional collaboration, Mentoring junior staff, Complex information communication
Technologies
Regulatory submission systems, Health authority interaction platforms
Responsibilities
Develop and execute global regulatory strategies, Collaborate with regional counterparts to align strategies, Create and submit compliant regulatory documents, Manage regulatory submissions, Support health authority interactions, Ensure accurate global reporting, Lead and mentor junior staff