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SUN PHARMA
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Manager-Regulatory & Business Continuity - US Market

Manager-Regulatory & Business Continuity - US Market

SUN PHARMA

5 - 9 years

0 Lacs

haryana

Posted:16 hours ago| Platform: Shine logo

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Skills Required

chemistry manufacturing stability protocol change control regulatory compliance regulatory submission cmc controls life cycle management quality dossiers new submissions review documents development report scale up report specification analytical validation exhibit batches response to deficiency lifecycle management variation annual notification labelling approval ectd compilation reposition of comprehensive product information regulatory filing impact

Work Mode

On-site

Job Type

Full Time

Job Description

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 approvals for US and OAM regions. - Review change control and file variations as per country requirements. - eCTD compilation. - Ensure the reposition of comprehensive product information into a central repository. - Review regulatory filing impact of variations, change controls, etc. Qualifications Required: - Bachelor's degree in a related field (e.g., Pharmacy, Chemistry, Regulatory Affairs). - Knowledge of regulatory requirements for drug formulations. - Strong attention to detail and analytical skills. If there are any additional details of the company in the job description, please provide them.,

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Manager-Regulatory & Business Continuity - US Market