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SUN PHARMA logo
Manager-Regulatory & Business Continuity - US Market SUN PHARMA

5.0 - 9.0 years

0 Lacs

haryana

On-site

You will be responsible for regulatory submission of new products, variations, response to queries, and life cycle management for the US and OAM regions. This will involve preparation of quality dossiers to ensure timely approvals. Key Responsibilities: - Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. - Review documents such as Development report, scale up report, specification, stability protocol, analytical validation, etc., before initiation of Exhibit batches for adequacy. - Review & prepare responses to deficiencies to enable approval of products filed to regulatory agency. - Prepare and review variations, Annual notifications, and labelling...

Posted 17 hours ago

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