Job Description Summary

Regulatory Affairs Associate is responsible for the timely preparation and submission of adequate and accurate ANDAs and supplements in eCTD format through effective interactions with various stakeholders pertaining to documents that are a part of submission. Also can responsible for oral solids (tablets, capsules) or sterile liquids dosage forms for the R&D pipeline, as well as marketed products. Evaluates the quality and content of dossiers to ensure fast product

Job Description

Collate and review CMC documents (i.e. Master Formula Card, PDR, BMR, BPR, Specifications, Validation reports etc.) from F&D, ADL, QA, production, packaging department and review of data for ANDA preparation, deficiency response, annual reports and supplements.Prepare and review the ANDA’s sections.Compile controlled correspondences for excipients, Q1/Q2 queries, BE guidance and general queries to FDA.Assist in the development of regulatory strategies & implementation in an effort to manage complex issues that may have a significant impact on the Company’s internal and external product portfolio and product approval process.Knowledge sharing sessions to be conducted as and when needed

Qualification : M.Pharm

Experience: 1 year CMC in Injectables formulation