Job Description

Prepare and compile Drug Master Files (DMFs) for China in compliance with regulatory guidelines. Conduct thorough reviews of technical and regulatory documentation to ensure accuracy and compliance. Prepare and submit responses to deficiency letters (DL) from regulatory authorities. Manage the entire regulatory life cycle of API products, including updates, renewals, and variations. Work closely with internal teams (R&D, Quality, Manufacturing) and external regulatory agencies to ensure smooth approvals and compliance. Maintain up-to-date knowledge of global regulatory requirements and ensure adherence to the latest guidelines. 5-10 years of experience in Regulatory Affairs (API) with hands-on expertise in China DMF compilation, review, and submission Strong understanding of global regulatory guidelines, especially China requirements. Ability to analyze and interpret regulatory requirements with precision. Excellent written and verbal communication to effectively interact with regulatory authorities and internal stakeholders. Proactive approach to identifying regulatory challenges and developing solutions. Note: Candidates may be considered for positions in Regulatory Affairs specializing in Active Pharmaceutical Ingredients (API) with an interest in working in Emerging Markets (ROW) .