Manager, Government Relations

Amneal Pharmaceuticals; Agra District; On-site; INR 1,500,000 - 4,000,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India is seeking an experienced Regulatory Affairs specialist to manage submissions for FDA, CDSCO and other authorities. You will coordinate with internal teams to gather documents and ensure timely approvals.

The role requires a B. Pharm and 10+ years of regulatory experience, with preference for M. Pharm. Joining within 30 days and strong knowledge of Drugs & Cosmetics Act and related rules are essential.

Qualifications

• 10+ years of regulatory affairs experience in pharma
• Experience with FDA, CDSCO, NDPS Act and related rules
• Proven ability to coordinate cross-functional teams

Responsibilities

• Prepare and submit regulatory applications through online portals
• Coordinate with internal stakeholders to gather required documents
• Handle regulatory queries and provide timely responses to authorities
• Track applications and ensure timelines align with business needs

Skills

Regulatory filings

Government liaison

Stakeholder coordination

Documentation management

Education

B. Pharm

M. Pharm

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