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Regulatory Affairs Specialist is responsible for ensuring that medical devices comply with all applicable regulations in India and international markets

Clinical batch data review, method validation, and stability study evaluations as per cGMP & regulatory norms. Routine analysis of clinical samples and stability samples. 

Maintain effective relationship with the end stakeholders medical scientific community within the allocated Global Business Unit and product – with an end objective to develop education and communication content as per requirement

Support Cross-functional team like Analytical Development, Formulation Development during product development and align documentation as per HC guidelines and Extend support for any other Regulatory related Function.

Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufacturing locations.

Post-Graduate M.Sc. in Biochemistry, Biotechnology, Microbiology, Life sciences.1-6 years of hands-on experience in relevant field, preferred Vaccine, Biotech background.

Looking for candidates with relevant experience in OSD regulated plant. RMG, FBE,FETTE, Auto coaters, Bottle Packing line with track and trace systems.

B.Pharm, M.Sc, B.Sc ; Hands on experience in LIMS,HPLC/FP Analysis.

M.Pharm, B.Pharm, M.Sc, B.Sc ; experience in production planning, change control, line clearance, Amneal Pharmaceuticals