Sr. Manager DRA

7 days ago

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

Role & responsibilities

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

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.

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