Manager, Government Relations

Amneal Pharmaceuticals LLC; Bharuch District; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India seeks an experienced Regulatory Affairs professional to prepare and submit applications under the Drugs & Cosmetics Act, coordinating with FDA, CDSCO, and other authorities. You will manage documentation for forms and ensure timely status updates.

The role involves liaising with internal teams, handling online portals like SUGAM, IDML, IFP and Unified CBN Portal, and ensuring compliance with NDPS and Gujarat Prohibition Act. Joining within 30 days is expected.

Qualifications

• Must hold B. Pharm; M. Pharm preferred for advanced responsibilities.
• Experience with regulatory submissions under Drugs & Cosmetics Act and Rules.
• Strong coordination with FDA, CDSCO, Prohibition & Excise, Narcotics authorities.

Responsibilities

• Prepare and submit regulatory applications and ensure timely approvals.
• Coordinate with internal stakeholders for technical documents and information.
• Handle regulatory queries and provide timely responses to authorities.
• Track applications to meet timelines and business needs.

Skills

Regulatory filings

Coordination

Documentation

Project coordination

Education

B. Pharm

M. Pharm

Tools

SUGAM

IDML

IFP

Unified CBN Portal

Job 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

Education:

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience:

• 10 years or more in 10 - 12 Years