Dharmender Singh Chaudhary

Lead-national Drug Regulatory Affairs @Syngene International Limited

New Delhi, IN

Leading a team of experienced regulatory affairs managers. Building regulatory strategy at the outset of a project and ensure its successful execution. Responsible for submissions of phase I-IV clinical trial applications, MAA, NDA, BLA, BA-BE studies, post approval changes, manufacturing permissions and related licenses, product permissions, imports and exports authorizations, WHO-GMP, COPP, etc. Lead point of contact for interactions with regulatory agencies in India (Central and State). Working in collaboration with CDSCO (Central and Zonal offices), SLA, CBN, NCB, DBT, DSIR, RCGM, IPC, DoP, NPPA, NIB, CDL, CDTL etc.Advocate policy shaping as per business model of company and work closely with associations like FICCI, IPA, USIBC, State Government designates etc.

Cranfield University

Master, clinical research

Delhi University

B.Sc., Life Science