Independently draft, review, compile and publish ANDA submissions in eCTD format.
Draft, review, compile and publish CMC post-approval submissions like supplements (PAS, CBE-30, and CBE), annual reports, and PADER’s
Troubleshooting validation errors prior to the ANDA, SPL, and supplement submissions
Drafting deficiency letter responses and coordinating with cross-functional teams to obtain accurate documentation. Responsible for assembly of ANDA submissions working directly with CMO’s and development partners.
Evaluating change controls and providing regulatory assessment in Track-wise system/ Quality Assurance Management System
Drug Master File review during the pharmaceutical drug development
Applying knowledge of ICH, USP (United States Pharmacopeia) /Eu Ph. (European Pharmacopeia) and 21 Code of Federal Regulations (21 CFR) on various submissions
Communicating with USFDA/ Health Authority on the status of the submissions
Track Regulatory activities via project management tools such as Excel, MS project, etc
Organize and update Regulatory files in internal drives.
Responsible for labeling generation including inserts, container and carton labels, patient brochures, etc., and Labeling submissions to FDA
Responsible for preparation of post-marketing reporting such as 15-Day MEd Watch’s, Periodic Safety Reports, compiling relevant information provided by partners and CMO’
Responsible for compiling information required for a drug listing.
Communicate and provide information to partners upon request. Provide presentation material for management updates.
Partner owned ANDAs: * Communicate and provide information to partners upon request
Partner owned ANDAs: * Work closely with partners and CMO’s for labeling development and review.