The Manager, Regulatory Affairs – CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products.
The Selected candidates will work on DST sponsored project at Membrane Science and Separation Technology Division, CSIR-Central Salt and Marine Chemicals Research Institute
Responsible for In-process production related activities in DP manufacturing, filling, and packing sections. Preparation of batch manufacturing records, process validation protocol/report of DP area and its associated records.
Review documents required for regulatory submissions across global markets, including product development reports and scientific justifications for responding to regulatory queries.
M.Sc, M.Tech. Bioinformatics/ Biotechnology/ Life science, Biomedical Sciences/Engineering, Veterinary or relevant Life science discipline), with minimum of 55% marks.
To design and conduct experiments for preformulation, formulation optimization of Microsphere and long acting complex non oral dosage form based on QbD approach. To execute the experiments as per Design of experiments
Stallion Laboratories incorporated in 1988 as an integrated private sector Pharmaceutical Formulation Manufacturer, has acquired an unmatched record of managing niche product in formulations with a WHO GMP approved production facility