Job Summary

We are seeking a dynamic, motivated and experienced member in our Regulatory Affairs team. This position will be based at Delhi and the candidate should have at least 8-12 years of experience in Regulatory Affairs. Preferably, complete knowledge of Indian Regulatory Requirements with in-depth understanding of D&C Act, NDCTR, GMP, GCP, DMR, etc. This person will be responsible for handling (reviewing, submitting & follow up) applications pertaining to New Drug, Subsequent New Drugs, FDC, Biological (Vaccine, Biosimilar, CGT), GCT, Medical Device, BE for Export, Written confirmation, Cosmetics, etc. Experience will not be a barrier for the right candidate.

Roles & Responsibilities

• You will be responsible for liaising with Central Drugs Standard Control Organization (CDSCO), Zonal offices as well as State Drugs Offices for necessary Drugs approvals to support markets in India and emergi...