(Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing
Core
Executes and manages regulatory submissions for CMC (Chemistry, Manufacturing, and Controls) matters to support drug development and post-market initiatives.
Role type
Manager, CMC Regulatory Affairs
Builds
Regulatory submission dossiers for Health Authority interactions and registration approvals
Domain
Pharmaceutical R&D / Regulatory Affairs
Deliverable
client delivery
Required skills
CMC regulatory submission management, Health Authority interaction, sample registration testing, change proposal evaluation, compliance with SOPs and regulations
Preferred skills
Advanced degree, experience with CMC regulatory frameworks
Technologies
NIFDC, IDC
Responsibilities
Execute and manage regulatory submissions for assigned projects, prepare CMC submission dossiers, participate in Health Authority interactions and consultation meetings, handle sample registration testing, support on-site inspections, evaluate change proposals for regulatory impact
Seniority
Manager, hands-on IC
