Head of Regulatory Affairs

Responsibilities

• Take full ownership of the end-to-end registration and filing process for innovative drugs (small molecules/biologics) in the U.S. market
  , lead the coordination, compilation, review, and submission of IND, NDA/BLA and other filing documents, ensuring compliance with FDA regulatory requirements.
• Serve as the primary point of contact with the FDA
  , establish and maintain a close and efficient communication mechanism, including organizing key meetings such as Pre-IND, EOP2, and Pre-NDA, following up on FDA feedback, and driving issue closure.
• Formulate overall registration strategies, optimize filing pathways by integrating product R&D progress and the latest FDA regulatory trends, mitigate registration risks, and ensure the achievement of filing milestones.
• Coordinate cross-functional internal resources (R&D, Clinical, Manufacturing, etc.), promote the collaborative output of registration-related documents, and ensure the efficient advancement of filing work.
• Monitor updates to FDA regulations and industry guidelines, interpret policy impacts, and provide professional support for the company's innovative drug R&D and registration decisions.

• Master’s degree or above in Pharmacy, Biomedical Sciences, Clinical Pharmacy, or related fields; 8+ years of experience in innovative drug registration
  , with at least 3 years of leading FDA filing experience (must have successful IND/NDA/BLA filing track record).
• Profound knowledge of FDA drug registration regulations (21 CFR) and filing processes, familiarity with ICH guidelines, and strong professional registration expertise and compliance risk management capabilities.
• Excellent English proficiency in listening, speaking, reading, and writing
  , capable of independent professional communication with the FDA (meetings, emails, written responses, etc.).
• Strong project management, cross-functional coordination, and problem-solving skills; high resilience to pressure and ability to manage multiple parallel projects.
• Preferred qualifications:
  
  Experience in biologic or first-in-class innovative drug filings; RAC (Regulatory Affairs Certification) holder.