APDM Pharmaceuticals Private Limited has its office in Ahmedabad with all QA and regulatory support staffs for managing CDO and CDMO projects ,vendor Audits, BA BA monitoring, project and Engg team.
Review and Finalize the preparation of new drug submissions, deficiencies to regulatory letters and post approval activities for the given portfolio of products.
USV Private Limited is a prominent Indian multinational pharmaceutical and biotechnology company founded in 1961, specializing in diabetes and cardiovascular therapeutics
PhD (Life Sciences) OR PharmD OR M.Pharm/M.Sc with a good understanding of clinical research and medical communication. Preferable to have some experience working on Global Medical Value, GMV Dossiers.
The role involves handling initial submissions, deficiency management, post-approval variations and lifecycle management activities in compliance with global regulatory requirements.