Regulatory Affairs Specialist - CMC (USFDA)

As a Regulatory Affairs Manager specializing in CMC, you will be responsible for leading and managing all CMC regulatory activities related to USFDA submissions, specifically focusing on ANDA preparation, review, and filing. Your role will involve overseeing the compilation and timely submission of Annual Reports, amendments, and responses to deficiencies. You will collaborate with cross-functional teams such as Quality Assurance, Production, and R&D to gather the necessary documentation and data required for regulatory submissions. A significant aspect of your responsibilities will include reviewing and ensuring compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data. It will be essential for you to coordinate effectively with manufacturing units to ensure that products and processes align with regulatory requirements. Additionally, staying informed about the evolving USFDA regulations will be crucial, enabling you to provide impact assessments and strategic guidance to the organization. To excel in this role, you should possess a minimum of 7-10 years of hands-on experience in Regulatory Affairs CMC, with a specific focus on USFDA filings, particularly ANDAs. A strong understanding of ICH guidelines, USFDA regulations, and the regulatory frameworks applicable to generic drug products will be required. You should also have experience in preparing and reviewing technical documents in Module 2 & 3 (CTD format) and exposure to quality systems, BMR review, and interaction with production/plant teams. Your ability to manage the end-to-end submission lifecycle, including post-approval changes and correspondence with USFDA, will be critical to your success in this role.,