Ast. manager / manager / sr. manager - regulatory affairs (clinical trials)

Role :

Responsible for regulatory activity related to clinical section for US, 'EU, WHO, Canada, Australia, New Zealand and South Africa Markets

Key Responsibilities :

 Preparation of bioequivalence related sections of ANDA product dossiers as per current regulatory guidelines

• Ensure timely preparation of amendments related to bioequivalence to expedite approvals
• Review of BE protocol for all market including ROW market
• Review of bio-waiver information and clinical strategy before start of clinical study.
• Confirmation of reference product for EU countries for clinical study
• Review and Preparation of 2.4 (non-clinical review) and 2.5 (clinical review) module for EU submissions

 Review of Sm PC, PIL, Labeling for US, EU and other markets with reference product to keep the generic product labeling up to date.

Key Activities :

 Review of technical documents (clinical) on receipt from various Departments before inclusion in dossiers.

 Attend meetings with QPPV for Sm PC and PIL related changes.