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?
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