10 - 17 years
9 - 18 Lacs
Posted:2 days ago|
Platform:
Work from Office
Full Time
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.
• 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.
Randstad
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