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 : Regulatory Affairs Associate
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
Candidate Profile : M.Pharm ; 1 year CMC in Injectables formulation
Additional Information
Experience : 1 year
Qualification : M.Pharm
Location : Digha - West Bengal
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 30th June 2024
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