Manager -2

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Key Responsibilities

Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.

Area Of Responsibility

New submissions:

Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.

Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy.

Approval:

Review & prepare response to deficiency enabling approval of products filed to regulatory agency.

Lifecycle management for drug formulations:

Prepare and review variation, Annual notification and labelling approval for US and OAM

Review of change control and file variation as per country requirement

Regulatory compliance:

eCTD compilation

Ensure reposition of comprehensive product information into central repository

Review regulatory filing impact of variations, change controls, etc.

Competencies Required:

Experience of USFDA market.