Manager Drug Regulatory Affairs
1 week ago
Job Description:
Responsible for leading and managing all regulatory activities for the Indian domestic market to ensure timely product approvals, license renewals, and compliance with CDSCO and State FDA regulations.
Key Responsibilities:
• Oversee submission, approval, and renewal of product licenses, manufacturing, and
marketing authorizations.
• Ensure compliance with Drugs & Cosmetics Act, Schedule M, and other applicable
regulations.
• Liaise with CDSCO, State FDA, and other regulatory authorities for product-related matters.
• Review and approve dossiers, product artworks, and labelling as per regulatory norms.
• Monitor changes in drug regulations and implement necessary updates.
• Guide the regulatory team and coordinate with R&D, QA, QC, and Production for
documentation.
Preferred candidate profile
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