**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 geographies
+ Mentor the CMC regulatory team in submission ...