Granules India is a vertically integrated, high-growth pharmaceutical company with 38 years of proven performance and increasing performance and increasing presence across the world
Regulatory Submissions: Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations, while ensuring compliance with relevant guidelines and reguiations.API Equipment Handling.
MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine / pharmacology etc.) with medical council certification required.
Literature review for product development for US/ EU/ ROW market especially complex injectable’s like Liposomes, Nanoparticle suspension, Microspheres, Suspension’s, Emulsion’s, Lyophilized products, Peptide Injectable’s, Drug delivery systems.
This role represents the CP Expert Team to the global cross functional drug discovery and development project teams, in close collaboration with colleagues in Biostatistics, Data Sciences, Clinical Biomarkers and Diagnostics, Research, Clinical Development and other colleagues within the R&D organization.