Amneal Pharmaceuticals – Hiring for Regulatory Affairs – Post Approval in Ahmedabad

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a global pharmaceutical company dedicated to making healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 270 high-quality medicines. With a team of 7,500+ colleagues, we are committed to innovation and excellence in the pharmaceutical industry.

Position Available

Role: Regulatory Affairs – Post Approval

Job Location: Ahmedabad

We are looking for candidates with the following qualifications and experience:

• Department: Regulatory Affairs
• Designation: Executive/Senior Executive
• Location: Ahmedabad
• Qualification: B. Pharm/M. Sc./M. Pharm
• Experience: 2-7 Years

Required Skills:

1. Good knowledge of ANDA submission activities and post-approval procedures, including related ICH and USFDA guidelines.
2. Experience with API DMF review concerning USFDA regulatory requirements.
3. Exposure to Solid oral dosage forms, Sterile dosage forms, complex dosage forms, and topical/Inhalation dosage forms, including a basic understanding of the manufacturing process and key regulatory aspects.
4. Ability to review change cases concerning ICH quality/post-approval USFDA guidance, with an understanding of post-approval submission guidelines and procedures for Annual Reports, CBE 0, CBE 30, and PAS filing.
5. Proficient in drafting Annual Reports with required submission data as per USFDA guidance.
6. Experience in drafting controlled correspondence and Briefing Packages to FDA on specific cases as needed for assigned projects.
7. Awareness of FDA recommendations regarding commercial marketing status notifications, including content and time frames.

How to Apply:

nterested candidates can share their CV with the following email addresses:

• kavitriy@amneal.com
• yash.ojha@amneal.com