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 2 weeks ago

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Manager, Regulatory Affairs APAC Teva Pharmaceuticals

10.0 - 15.0 years

15 - 20 Lacs

bengaluru

Hybrid

Role & responsibilities Management of the submission and approval process for Teva products in APAC Region (Australia, New Zealand, Singapore, Malaysia etc) to support business opportunities for the company. Management of regulatory compliance including product maintenance, data sheets, labelling, regulatory compliance files and regulatory databases. Support new product launch activities including coordinating regulatory requirements, artwork approval and providing technical input into any product related materials required for market introduction. Regulatory Submissions Manage all submissions and maintenance activities related to Branded/Specialty and Generic products in APAC region. Ensure...

Posted 3 months ago

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