Independently draft, review, compile and publish NDA, 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
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.
Bachelor’s Degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science or Chemistry.