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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

As a Regulatory Submission Specialist, your role involves handling the regulatory submission of new products, variations, and responses to queries for the US and OAM regions. Your primary responsibility is to prepare quality dossiers to ensure timely approvals for life cycle management. Key Responsibilities: - Review and prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. - Review various documents such as Development reports, scale-up reports, specifications, stability protocols, and analytical validations before initiating Exhibit batches. - Prepare responses to deficiencies to facilitate the approval of products filed with regulatory agencies. - Manage the ...

Posted 6 days ago

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