Assistant Manager - Regulatory Affairs API - China Market

As a Regulatory Affairs Specialist, your role will involve preparing and compiling Drug Master Files (DMFs) for China in compliance with regulatory guidelines. You will be responsible for conducting thorough reviews of technical and regulatory documentation to ensure accuracy and compliance. Additionally, you will prepare and submit responses to deficiency letters (DL) from regulatory authorities and manage the entire regulatory life cycle of API products, including updates, renewals, and variations. Collaboration with internal teams (R&D, Quality, Manufacturing) and external regulatory agencies will be essential to ensure smooth approvals and compliance. It will be crucial for you to maintain up-to-date knowledge of global regulatory requirements and ensure adherence to the latest guidelines. Your key responsibilities will include: - 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. In order to excel in this role, you should possess the following qualifications and skills: Qualifications: - M.Pharm / B.Pharm / M.Sc. in Chemistry or a related scientific discipline. Experience: - 5-10 years of experience in Regulatory Affairs (API) with hands-on expertise in China DMF compilation, review, and submission. Additional details about the company were not provided in the job description.,