Amneal Pharmaceuticals Hiring for Regulatory Affairs – Executive, Sr Executive

Amneal Pharmaceuticals is hiring Executive & Senior Executive – Regulatory Affairs (Post Approval) for its Ahmedabad facility. If you have expertise in ANDA submissions, USFDA regulations, and post-approval processes, this is an excellent opportunity to advance your career with a leading global pharmaceutical company.

Job Details

 Job Position: Regulatory Affairs – Executive, Sr Executive

Company: Amneal Pharmaceuticals

Location: Ahmedabad, India

Qualification: B.Pharm / M.Sc. / M.Pharm

Experience: 2-7 Years

About Amneal Pharmaceuticals

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a leading global pharmaceutical company with a diverse portfolio of 270+ high-quality medicines. With a workforce of 7,500+ employees, Amneal is dedicated to delivering affordable and innovative healthcare solutions worldwide. The company specializes in the development, manufacturing, and distribution of complex generic and specialty pharmaceuticals, making it a preferred employer in the industry.

Key Responsibilities

As a Regulatory Affairs Executive/Sr Executive, you will be responsible for:

• ANDA Submission & Post-Approval Activities: Managing submission procedures and ensuring compliance with ICH and USFDA guidelines.
• API DMF Review: Evaluating Drug Master Files (DMF) per USFDA regulatory requirements.
• Regulatory Documentation: Preparing Annual Reports, Controlled Correspondence, and Briefing Packages for USFDA submissions.
• Change Management: Reviewing post-approval changes as per ICH quality guidelines.
• Product Expertise: Handling regulatory aspects of solid oral, sterile, topical, inhalation, and complex dosage forms.
• Regulatory Compliance: Ensuring commercial marketing status notifications comply with FDA recommendations.

Required Skills & Competencies

•  Strong knowledge of ANDA submission activities and post-approval procedures.
• Familiarity with USFDA and ICH regulatory guidelines.
• Experience in solid oral, sterile, complex, and inhalation dosage forms.
• Expertise in Annual Reports, CBE-0, CBE-30, PAS filings, and post-approval changes.
• Ability to draft Controlled Correspondence & Briefing Packages for the FDA.
• Understanding of FDA requirements for commercial marketing notifications.

How to Apply?

If you meet the qualifications and experience requirements, send your updated CV to the official email IDs below: 📩 kavitriy@amneal.com
📩 yash.ojha@amneal.com