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Sr. Manager DRA (Domestic Market)

Sr. Manager DRA (Domestic Market)

12 - 16 years

|

18 - 20 Lacs

Posted:6 hours ago| Platform:

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Skills Required

drug regulatory affairs dra domestic market cdsco ctd regulatory affairs dossier

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

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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