JOB DESCRIPTION
Position : Head Biologicals – Regulatory CMC
Grade : G8
Job Location : Gurgaon (preferable)/Baroda/Mumbai
Education : M.Pharm/M.Tech/MS/ PhD (Pharmaceutics/Biotechnology)
Department : Global Regulatory Affairs – Innovative Medicines
Job Responsibilities
Lead the global regulatory team in the CMC strategy development for established Medicines (Biologics) being developed for US, EU, Canada, Australia, Brazil and RoW markets.Coordinate with peers in cross functional team for data driven decision making process for CMC regulatory strategies for established products (Biologics) to be launched for US and other advanced markets like EU, Canada Australia, Brazil, etc.,Drive the development projects in collaboration with leads from CFT and project management team towards the regulatory milestones across various geographiesMen...