Amneal Pharmaceuticals has opened a new job for the post of Executive – Regulatory Affairs at its Ahmedabad, Gujarat office. This is a good chance for candidates who have worked in Regulatory Affairs, mainly in ANDA submissions and post-approval work. If you have 5 to 8 years of experience in this field, you can check the full details below and apply.
Amneal Job Vacancy Overview
| Details | Information |
|---|---|
| Company | Amneal Pharmaceuticals |
| Position | Executive – Regulatory Affairs |
| Location | Ahmedabad, Gujarat, India |
| Department | Regulatory Affairs |
| Experience | 5–8 Years |
| Qualification | B.Pharm (Required), M.Pharm (Preferred) |
About the Job
This role is for someone who already knows how ANDA (Abbreviated New Drug Application) submissions work and has hands-on experience with post-approval regulatory work. The person hired for this job will work closely with different teams to make sure all regulatory documents are ready and submitted on time, as per USFDA and ICH guidelines.
Job Responsibilities
The Executive – Regulatory Affairs will be responsible for the following tasks:
- Handle ANDA submission activities and post-approval regulatory procedures
- Prepare and review submissions as per ICH and USFDA guidelines
- Review change control cases based on ICH Quality and USFDA post-approval guidance
- Prepare and compile Annual Reports, CBE-0, CBE-30, and Prior Approval Supplement (PAS) submissions
- Do a preliminary review of regulatory submission packages
- Support commercial marketing status notification submissions as per FDA rules
- Work with cross-functional teams to collect submission documents on time
- Make sure regulatory documents are drafted, compiled, and submitted without delay
- Keep regulatory information and documentation updated
- Draft and review CTD modules with correct accuracy
- Work on sterile dosage forms and complex injectable regulatory submissions
Required Skills
To apply for this job, candidates should have the following skills:
Regulatory Knowledge
- Strong knowledge of ANDA submissions
- Good understanding of ICH and USFDA regulatory requirements
- Experience in post-approval regulatory submissions
Technical Skills
- Knowledge of sterile and complex injectable dosage forms
- Good hands at regulatory documentation and CTD drafting
Other Skills
- Good communication and coordination skills
- Ability to handle multiple regulatory projects within deadlines
Educational Qualification
- Required: B.Pharm
- Preferred: M.Pharm
Experience Required
Candidates should have 5 to 8 years of relevant work experience in Regulatory Affairs.
Job Location
Ahmedabad, Gujarat, India
Why Join Amneal Pharmaceuticals?
Here are a few reasons why this job can be a good move for your career:
- Chance to work with a global pharmaceutical company
- Exposure to international regulatory submissions
- Good scope for career growth in Regulatory Affairs
- Friendly and growth-focused work environment
About Amneal Pharmaceuticals
Amneal Pharmaceuticals is a global pharmaceutical company that makes and supplies a wide range of generic and specialty medicines. The company is known for its strong presence in the US and Indian pharma markets, along with steady growth in complex generics and injectable products. Amneal focuses on quality, innovation, and timely delivery of medicines across the world.
How to Apply
Candidates who match the above requirements can apply through the official Amneal Pharmaceuticals Careers Portal. Make sure your resume is updated before applying.