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AbbVie

Senior Manager, Regulatory Affairs

Hybrid
All Other
Added
16 days ago
Location
Type
Full time
Salary
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Related skills

regulatory affairs clinical trials pharmaceuticals oncology cde

📋 Description

  • Develop and execute regulatory strategies for oncology products in China
  • Lead preparation and submission of clinical trial applications to CDE
  • Manage regulatory agency interactions and address review questions
  • Monitor and interpret Chinese and global regulatory regulations
  • Collaborate with global and local stakeholders on regulatory alignment
  • Provide regular updates to senior management on regulatory status

🎯 Requirements

  • Bachelor's degree or above in Pharmacy, Medicine, or Life Sciences
  • 10+ years regulatory affairs experience in pharma
  • Experience with China regulatory submissions and approvals
  • Oncology therapeutic area experience required
  • Direct interaction experience with CDE and health authorities
  • Experience leading complex cross-functional projects
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