* 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.

-Authoring, compilation and review of Module 1, Module 2 and CMC data of Module 3 in eCTD for Solid Orals and Oral Liquid dosage forms (USA market).-Evaluation, compilation, review and submission of high-quality deficiency response during registration and ensuring timely submission of deficiency response.-Review of R&D (Master Formula Record, Master Packaging Record, API & FP Specifications and STPs, Stability Protocols, etc.) and QA documents (BMRs, BPRs, Specifications, STPs, COAs, Validation Protocols and Reports, Stability Protocols and Stability Data etc.) from regulatory perspective and work with cross-functional teams for documents required for regulatory submission.-Review of drug product labelling.-Processing of PDF files for sequence compilation in eCTD format.- Review, assessment and approval of change controls.-Review and compilation of Annual Reports.-eCTD compilation, verification and publishing activity.