Endo India Par Formulations is a pharmaceutical company that develops, manufacturers and markets safe, innovative and cost effective pharmaceuticals that help improve patient quality of life. At Endo our investment in state-of-the-art equipment and facilities, commitment to ethical standards, and growing portfolio of products makes us a company where you can enjoy a productive career with long-term potential.
Post : CMC Regulatory Affairs Deputy Manager
The Regulatory Affairs Deputy Manager is responsible for the timely preparation and submission of adequate and accurate ANDAs in eCTD format through effective interactions with various stakeholders pertaining to documents that are a part of submission. May be 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 approval (within GDUFA goal date).
• 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, review and, following final review and authorization, submit ANDA’s.
• Conduct gap analysis of filed ANDA’s and prepare mitigation plan.
• 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.
Experience : 7-10 years CMC in Injectables formulation
Qualification : B.Pharm/M.Pharm
Location : Digha, West Bengal
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 20th November, 2023
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