Manager, Government Relations
Manager, Government Relations
Amneal Pharmaceuticals- Posted 13 hours ago
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Job Description
Description
JOB DESCRIPTION
QUALIFICATIONS
JOB 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
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 10 years or more in 10 - 12 Years
More Info
Key Skills
Gujarat Prohibition Act
Online regulatory portals
Regulatory applications
IFP
NDPS Act Rules
Drugs Cosmetics Act
IDML
SUGAM
Unified CBN Portal
About Company