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Terapia - a SUN PHARMA Company
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Manager-Regulatory & Business Continuity - US Market

Manager-Regulatory & Business Continuity - US Market

Terapia - a SUN PHARMA Company

0 years

0 Lacs

Gurgaon Haryana India

Posted:3 months ago| Platform:

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Skills Required

management manufacturing controls development report stability initiation

Work Mode

On-site

Job Type

Full Time

Job Description

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Title: Manager-Regulatory & Business Continuity - US MarketDate: Jun 23, 2025Location: Gurgaon - R&DCompany: Sun Pharmaceutical Industries Ltd

Job Summary

Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region throughpreparation 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.

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Manager-Regulatory & Business Continuity - US Market