Manager, Government Relations

Company : Amneal

Job Type : Full Time

Bharuch, India

Job Description - Manager, Government Relations

Description

Description:

Prepare and submit various regulatory applications, including Form 29, Form 11, Form 10, CT-11, CT-17, Forms 25 & 28, Chemist Approval, Written Confirmation, WHO-GMP Certification, Dual-Use NOC, RS-II, AC-II, MA-I & MA-II, Export Authorization and Import Authorization, and ensure timely follow-up and approvals from FDA, CDSCO, Prohibition & Excise, and Narcotics authorities.

Possess good working knowledge of the Drugs & Cosmetics Act and Rules, Gujarat Prohibition Act, and NDPS Act/Rules.

Coordinate with internal stakeholders to obtain technical documents and information required for regulatory filings and government submissions.

Prepare and submit applications through online regulatory portals, including SUGAM, IDML, IFP, and Unified CBN Portal.

Handle regulatory queries, deficiencies, and clarifications raised by government authorities and coordinate internally for timely responses.

Liaise and maintain effective coordination with government authorities, including FDA, CDSCO, Prohibition & Excise Department, Narcotics authorities, and Industries Commissionerate, as required.

Track applications and approvals to ensure regulatory timelines and business requirements are met.

Joining requirement: Candidate should be available to join within 30 days

Qualifications

Education:

B. Pharm B. Pharm - Required

M. Pharm M. Pharm - Preferred

Experience:

10 years or more in 10 - 12 Years

Specialized Knowledge: Licenses:

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Manager, Government Relations

Job Description - Manager, Government Relations

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