Executive, Regulatory Affairs
Amneal Career Sites
Executive, Regulatory Affairs
About this role
Key Responsibilities
1. Dossier Preparation & Submissions
- Prepare, review, and submit CTD / ACTD / country‑specific dossiers for:
- New product registrations
- Line extensions (strength, pack size, shelf life)
- Variations and renewals
- Coordinate compilation of Modules 1–5 with QA, QC, R&D, CMC, PV, PM, and Manufacturing teams.
- Ensure dossier compliance with WHO, ICH, and local authority guidelines.
2. Regulatory Strategy & Market Support
- Support business development by providing regulatory feasibility and timelines for new markets/products.
- Assess regulatory impact for formulation/site changes.
3. Regulatory Lifecycle Management
- Manage post‑approval changes, including:
- CMC variations
- Labeling updates
- Artwork changes
- Track and ensure timely renewals/re‑registrations.
- Maintain approved product documentation and regulatory databases.
4. Health Authority Interaction
- Handle deficiency letters / queries from regulatory agencies.
- Prepare responses in coordination with internal stakeholders.
- Liaise with local agents, consultants, and partners for RoW countries whenever required.
5. Compliance & Intelligence
- Monitor regulatory guideline updates for RoW markets.
- Ensure submissions comply with the latest country requirements.
Markets Typically Covered (RoW)
- LATAM: Brazil, Mexico, Colombia, Peru, Chile, Guatemala
- MENA/GCC region
- CIS: Russia, Ukraine, Kazakhstan, etc.
- ASEAN: Philippines, Vietnam, Thailand, Malaysia, etc.
Required Qualifications & Experience
• Educational Background:
o M.Pharm / B.Pharm
• Experience:
o 3-9 years in Pharmaceutical Regulatory Affairs
Frequently Asked Questions
Is the salary disclosed for the Executive, Regulatory Affairs position at Amneal Career Sites?
The salary for this Executive, Regulatory Affairs role at Amneal Career Sites is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Executive, Regulatory Affairs position at Amneal Career Sites located?
This Executive, Regulatory Affairs role at Amneal Career Sites is based in Ahmedabad City, Gujarat, India. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Executive, Regulatory Affairs role at Amneal Career Sites full-time or part-time?
This is listed as a Full time position. It is posted as a Executive, Regulatory Affairs role at Amneal Career Sites.
How do I apply for the Executive, Regulatory Affairs position at Amneal Career Sites?
Click the "Apply Now" button on this page. You will be redirected to Amneal Career Sites's official application portal hosted on oraclecloud where you can submit your application directly.
When was the Executive, Regulatory Affairs job at Amneal Career Sites posted?
This Executive, Regulatory Affairs position at Amneal Career Sites was posted on Sep 11, 2026. Apply as soon as possible — early applications are often reviewed first.
Executive, Regulatory Affairs
Amneal Career Sites
You'll be redirected to Amneal Career Sites's official application page on oraclecloud.