Manager Drug Regulatory Affairs

1 week ago


Ludhiana, Punjab, India Randstad Full time ₹ 15,00,000 - ₹ 25,00,000 per year

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.

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