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.
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.
Ensure team members are trained and competent in all delivery areas. Assist the team during high work volumes by completing LTO accountabilities. Apply scientific knowledge to create compelling medical content and communications.
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.