Senior Manager, Regulatory Affairs
Core
Develop and execute regulatory strategies to support the initiation of first-in-human clinical studies for oncology products in China.
Role type
Senior Manager, Regulatory Affairs
Builds
Clinical trial applications and regulatory dossiers for oncology products
Domain
Pharmaceutical industry, Oncology, China regulatory environment
Required skills
Regulatory strategy execution, CDE submission management, Health authority interaction, Regulatory intelligence, Cross-functional leadership, Strategic planning
Preferred skills
Oncology therapeutic area expertise, Early clinical development experience, Multinational pharma environment experience
Technologies
CDE systems, Regulatory submission platforms
Responsibilities
Lead preparation and submission of regulatory dossiers for initial CTAs and amendments; Monitor and interpret changes in Chinese and global regulatory regulations; Lead regulatory interactions with CDE and other agencies; Collaborate with Quality Assurance to maintain compliance; Provide regular updates to senior management regarding regulatory project status.
Seniority
Senior, hands-on IC with leadership responsibilities