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Head of Regulatory Affairs
Core 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. Requirements: 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.
