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Regulatory Affairs Executive

Regulatory Affairs Executive

Kryptonite Medical Solutions

1 - 4 years

3 - 4 Lacs

Mumbai Suburban

Posted:1 month ago| Platform:

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Skills Required

Regulatory Guidelines FDA Regulatory Audits Submission Regulatory Reports commnincation skills Regulatory Documentation Regulatory Submissions Regulatory Affairs Regulatory Requirements Regulatory Issues Regulatory Operations Regulatory Compliance

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Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities Prepare dossiers, variations, renewals, and amendments for regulatory submissions to FDA and other global health authorities. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Maintain accurate records of all regulatory correspondence, reports, and audit findings. Ensure compliance with regulatory guidelines and requirements by reviewing documentation and conducting internal audits. Provide support during regulatory audits by gathering necessary information and preparing responses. Desired Candidate Profile 1-4 years of experience in Regulatory Affairs or related field (pharmaceutical industry). Bachelor's degree in Pharmacy (B.Pharma) or Science (B.Sc), preferably in a relevant specialization. Strong understanding of FDA regulations, regulatory operations, compliance, submissions, documentation, guidelines, issues, reports.

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