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, RD, 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 current 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 7-9 years in Pharmaceutical Regulatory Affairs

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Sr Executive, Regulatory Affairs (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad