Website Endo India
About Endo India
Endo India Par Formulations is a pharmaceutical company dedicated to the development, manufacturing, and marketing of safe, innovative, and cost-effective pharmaceuticals that aim to enhance the quality of life for patients. At Endo, we prioritize our investment in state-of-the-art equipment and cutting-edge facilities, uphold the highest ethical standards, and continually expand our product portfolio. This approach makes us an organization where you can build a rewarding and enduring career with ample long-term growth opportunities.
Job Post: CMC Regulatory Affairs Deputy Manager
Job Description
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).
Key Responsibilities:
- 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 a 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.
Additional Information
- Experience Required at Endo India: 7-10 years in CMC for Injectables formulation
- Qualification Required at Endo India: B.Pharm/M.Pharm
- Location: Digha, West Bengal
- Industry Type: Pharma
- Functional Area: Regulatory Affairs
- End Date: 20th November 2023
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