Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a globally recognized pharmaceutical company dedicated to making healthy living possible. With a team of over 7,500 professionals, Amneal develops, manufactures, and distributes a diverse portfolio of 270+ high-quality medicines. The company is currently hiring for the Regulatory Affairs – Post Approval department in Ahmedabad. If you have a background in pharmaceuticals and regulatory affairs, this could be your opportunity to join a leading player in the industry.
Job Overview
Amneal Pharmaceuticals is seeking experienced candidates for the position of Executive/Senior Executive in the Regulatory Affairs department. The role is based in Ahmedabad and requires a B. Pharm/M. Pharm/M. Sc. qualification with 2-7 years of relevant experience. This is an excellent opportunity for professionals looking to advance their careers in regulatory affairs within the pharmaceutical sector.
Key Responsibilities
The selected candidate will be responsible for:
- ANDA Submission and Post-Approval Procedures: Ensuring compliance with ICH and USFDA guidelines.
- API DMF Review: Reviewing Drug Master Files (DMF) in line with USFDA regulatory requirements.
- Dosage Form Expertise: Understanding solid oral dosage forms, sterile dosage forms, complex dosage forms, and topical-inhalation dosage forms, including their manufacturing processes and regulatory aspects.
- Change Case Review: Preliminary review of change cases in accordance with ICH quality and post-approval USFDA guidance.
- Annual Report Drafting: Preparing annual reports with submission data as per USFDA guidelines.
- Controlled Correspondence: Drafting controlled correspondence and briefing packages for the FDA as needed.
- Commercial Marketing Status Notification: Ensuring compliance with FDA recommendations for commercial marketing status submissions.
Required Skills and Qualifications
- Educational Qualification: B. Pharm, M. Pharm, or M. Sc. in a relevant field.
- Experience: 2-7 years in regulatory affairs, specifically in post-approval activities.
- Technical Skills:
- Proficiency in ANDA submissions and post-approval procedures.
- Knowledge of ICH and USFDA guidelines.
- Experience with API DMF reviews.
- Familiarity with various dosage forms and their regulatory requirements.
- Ability to draft annual reports, controlled correspondence, and briefing packages.
- Soft Skills: Strong analytical skills, attention to detail, and effective communication abilities.
Why Join Amneal Pharmaceuticals?
Amneal Pharmaceuticals is a global leader in the pharmaceutical industry, offering a dynamic work environment and opportunities for professional growth. By joining Amneal, you will be part of a team that is committed to improving global health through innovative and high-quality medicines.
How to Apply
Interested candidates can share their CVs at the following email IDs:
