Sr Mgr - Regulatory Compliance - Pharma

1. Familiarity and thorough knowledge of regulations for conducting clinical trials with all kinds of products - like, NCEs, NBEs, biosimilars, generics, biologicals, vaccines, medical devices, stem cells, generics, nutraceuticals, consumer products, cosmetics, herbal products, etc.

2. Familiarity and thorough knowledge of regulations of different types of clinical trials – drug trials (phase 2-4) , non-drug trials, BA/BE studies, phase 1 trials, PMS studies, special population studies, population based studies, first-in-man studies, observational studies, etc.

3. Thorough knowledge of drug development – experience in drug development would be essential, like - process development/preclinical studies/clinical studies/manufacturing etc..

4. Thorough knowledge of GMP, GCP, GLP and Ethical Guidelines

5. Demonstrated experience in regulatory inspections and audits

6. Has experience in direct dealing with CDSCO (DCGI), MoH, ICMR, DBT, DGFT, CBN, Port Offices and state regulatory authorities – close relationship with DCGI office is absolutely essential.

7. Has experience in preparing “all kinds” of dossiers and communications for regulatory submissions

8. Experience in preparation for NDAC meetings and attendance at NDAC meetings

9. Experience in safety reporting to Indian regulatory authorities

10. Familiarity with the current clinical regulatory situation/scenario in India