Regulatory Affairs Specialist II

• 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.