Job Description

Role & responsibilities - Review, compile and submit the Application dossiers (ANDA, MAA) to regulatory agencies like US-FDA, EMA, Health Canada, Australia and ROW countries. - Review and approve regulatory CMC documents being generated at R&D and commercial manufacturing facility such as development reports, BMR, BPR, Specifications, method validation reports, process validation reports, stability protocols, stability data etc. and ensure regulatory compliance. - Maintenance of the complete history of each Drug products (Filing history with agencies/customers, amendments).To coordinate in regulatory audits and provide regulatory support. - Coordination with internal and external stakeholders for regulatory filing related documentation. - Communicate the agency's comments/deficiencies to respective in house departments, prepare the response and submit it back to the agency. - Hands on experience of post approval variations and Annual reports. Preferred candidate profile Master of Pharmacy Perks and benefits As per Company Standards