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.