Manager Government Relations

Amneal Pharmaceuticals LLC; India; On-site; INR 1,500,000 - 2,400,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking an experienced Regulatory Affairs Specialist to manage submissions of Form 29, Form 11, Form 10, CT-11, CT-17, and other regulatory documents in India. The role requires coordinating with FDA, CDSCO, Prohibition & Excise, Narcotics authorities and ensuring timely approvals.

The candidate should have a B. Pharm (M. Pharm preferred) with 10+ years in regulatory filings, and be ready to join within 30 days. Strong dossier preparation skills are essential.

Qualifications

• 10+ years of regulatory affairs experience in pharma.
• Experience with government authorities (FDA, CDSCO, NDPS Act).
• Strong documentation and portal submission skills.

Responsibilities

• Prepare and submit regulatory filings and approvals.
• Coordinate with internal stakeholders for documents.
• Handle regulatory queries and provide timely responses.
• Track timelines for applications and approvals.
• Join within 30 days.

Skills

Regulatory submissions

Stakeholder coordination

Regulatory compliance

Documentation management

Education

B. Pharm

M. Pharm

Tools

SUGAM

IDML

IFP

Unified CBN Portal

Job description

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

Qualifications

Education:

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

Experience:

• 10 years or more in 10 - 12 Years