Senior Manager, Regulatory Affairs

📋 Description

• Develop and implement regulatory strategies for assigned oncology products to achieve business
• Provide regulatory leadership and strategic guidance throughout product development, registration
• Lead preparation, compilation, review, and submission of regulatory applications to NMPA and other
• Coordinate cross-functional activities required to support product registrations and approvals
• Manage regulatory agency interactions and address questions arising during the review process
• Ensure timely execution of all post-approval regulatory activities, including variations, renewals

🎯 Requirements

• Bachelor's degree or above in Pharmacy, Medicine, Pharmacology, Biology, Chemistry, Life Sciences
• Advanced degree (Master's, PharmD, PhD, or equivalent) preferred
• Minimum 10–15 years of regulatory affairs experience within the pharmaceutical industry
• Significant experience in China regulatory submissions, approvals, and lifecycle management
• Proven experience developing and implementing regulatory strategies for innovative pharmaceutical
• Oncology therapeutic area experience strongly preferred