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 SmPC, 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.

• Discuss and coordinate with cross-functional teams for finalization of documents

• Preparation and review of clinical section of product dossiers for ANDA filing.

• Preparing response of queries for USFDA & UK related to clinical section to facilitate product approval.

 Attend meetings with QPPV for SmPC and PIL related changes.