Executive - Regulatory Affairs
Current* Responsible for Drafting, Review and Compilation of required sections in M1, M2, M3 and M5 for Original Submissions. (Dosage forms includes OSD, Oral Liquids, Injectables).* Responsible for Preparation and Review of Labelling Pieces for Original and other regulatorysubmissions (such as PIL, Medication Guide, Instruction for Use, SBS, draft label for Artwork development and SPL).* Processing of PDF files as per regulatory requirement and eCTD compilation, verification and publishing activity.* Assessment, Evaluation and Compilation of high quality deficiency responses for deficiency received from Agency (i.e. IR, DRL, CRL etc.) during registration within stipulated timeframe.* Post approval submissions such as Annual Reports, CBE, CBE-30, PAS for life cycle management of approved products.* Review of R&D (MFC, MPR, Stability Protocols, API & FP Specifications and PDR etc) and CMC documents (BMRs, BPRs, Specifications, STPs, COAs, Validation protocols and Reports, Stability Protocols & Reports and Stability data etc.) from regulatory perspective and work with cross functional teams for tracking of submission documents.* Review and submission of controlled correspondences.
