Corporate Affairs Manager

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

Job summary

Amneal Pharmaceuticals LLC in Gujarat is seeking a Deputy Manager / Manager Government Relations (Corporate Affairs) to lead regulatory liaison and licensing for pharmaceutical manufacturing. The role requires deep knowledge of statutory approvals and interaction with state authorities.

You will manage submissions, ensure compliance with Drugs and Cosmetics Act and NDPS Act, coordinate with multiple departments, and maintain regulatory records. 10–12 years experience and B.Pharm/M.Pharm required.

Qualifications

• 10–12 years of regulatory experience in pharmaceutical manufacturing.
• Experience preparing and submitting regulatory applications and forms.
• Strong government liaisoning with Gujarat authorities.

Responsibilities

• Handle licensing, regulatory docs, and approvals for pharma operations.
• Submit forms and regulatory documents (29/11/10, CT-11/17, 25/28, WHO-GMP).
• Liaise with FDA, CDSCO, Prohibition & Excise, Narcotics authorities.
• Ensure compliance with Drugs and Cosmetics Act, Gujarat Prohibition Act, NDPS.
• Manage regulatory submissions via SUGAM, IDML, IFP, Unified CBN Portal.
• Handle Dual-Use NOCs and import/export authorizations.
• Coordinate with internal departments for docs and tech info.
• Address queries and deficiencies within timelines.
• Track applications, approvals, renewals, and maintain records.
• Preferred candidates with gov liaison skills in Gujarat.

Skills

Regulatory liaison

Govt. liaison

Licensing & approvals

Education

B.Pharm / M.Pharm

Tools

SUGAM

IDML

IFP

Unified CBN Portal

WHO-GMP

Job description

Deputy Manager / Manager Government Relations (Corporate Affairs)

• Experience: 10–12 Years
• Qualification: B.Pharm / M.Pharm
• CTC: 15–20 LPA
• Location: Dahej Gujarat

Job Responsibilities:

1. Handle regulatory documentation, licensing, and statutory approvals for pharmaceutical manufacturing operations.
2. Prepare and submit applications, including Forms 29, 11, 10, CT-11, CT-17, Forms 25 & 28, WHO-GMP, and other regulatory documents.
3. Liaise with FDA, CDSCO, Prohibition & Excise, Narcotics authorities, and Industries Commissionerate.
4. Ensure compliance with the Drugs and Cosmetics Act, Gujarat Prohibition Act, and NDPS Act/Rules.
5. Manage online regulatory submissions through SUGAM, IDML, IFP, and the Unified CBN Portal.
6. Handle Dual-Use NOCs, import/export authorizations, and other statutory permissions.
7. Coordinate with internal departments for regulatory documents and technical information.
8. Address regulatory queries, deficiencies, and clarifications within stipulated timelines.
9. Track applications, approvals, renewals, and maintain regulatory records.
10. Candidates with pharmaceutical industry experience and strong government liaisoning skills in Gujarat will be preferred.

[e-mail]

9550545943