To propose and fix the batch size i.e. of the Demo, Scale up, Exhibit and Commercial based on Equipment Capacity/Qualification, Scale Up factor calculations & annual requirements.
Responsible for preparation and review of the master documents of sterile manufacturing for parenteral facility. Responsible for preparation and review of protocols and reports based on the requirements.
Ensure assigned products remain in a validated and compliant state as per MS&T and regulatory expectations. Contribute to investigations and prepare OPV reports, PPQ documentation, regulatory responses, and scale up proposals.
MSc Chemistry or MPharma Pharmaceutical Chemistry. C-H Functionalization Strategies for Bioactive Theranostic Probes Targeting UTI- Causing Bacteria and their Application in Diagnostic Device Development
Development of novel therapeutic device and pharmacological strategies to overcome Time-Dependent Accumulation of Oxidized/ modified Albumin in Alcohol-Related Liver Disease ILBS, New Delhi.
experience in regulatory affairs or drug development within the pharmaceutical or related industry; Detailed knowledge of the global/regional drug regulatory approval process, submission standards, and health authority requirements
B. Pharm / M. Pharm, or M.Sc. in Life Sciences. Advanced proficiency in regulatory portals (SUGAM, NSWS) and expert-level understanding of the Drugs & Cosmetics Act and CDSCO guidelines. Elanco Animal Health
M.Pharm as Executive Pharmacokinetics. Literature search and study designing of Bioavailability and Bioequivalence studies of oral & non-oral products towards different regulatory submission. Sun Pharma