Manager, Government Relations

Amneal Pharmaceuticals; Dahej; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Gujarat seeks an experienced Regulatory Affairs professional to manage submissions and approvals under relevant acts and rules. You will coordinate with internal teams to gather required documents and file through online portals, ensuring timely responses to government inquiries. The role requires a B.

Pharm (M. Pharm preferred) with 10+ years of experience in regulatory submissions and liaison with authorities.

Qualifications

• Experience with regulatory filings under Drugs & Cosmetics Act and Rules.
• Ability to coordinate with internal stakeholders for required documents.
• Proficiency with online regulatory portals (SUGAM, IDML, IFP, Unified CBN Portal).

Responsibilities

• Prepare and submit regulatory applications and ensure timely approvals.
• Handle government inquiries, deficiencies, and clarifications.
• Liaise with authorities such as FDA, CDSCO, Prohibition & Excise, Narcotics for approvals.

Skills

Regulatory submissions

Stakeholder coordination

Document management

Online portal filings

Education

B. Pharm

M. Pharm

Job description

Description

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

Education

QUALIFICATIONS

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

Experience

• 10 years or more in 10 - 12 Years

Specialized Knowledge: Licenses: