Description

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 recent 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.

Qualifications

Required Qualifications & Experience
• Educational Background:
o M.Pharm / B.Pharm
• Experience:
o 7-9 years in Pharmaceutical Regulatory Affairs

📌 Senior Executive, Regulatory Affairs (Ahmedabad)
🏢 Amneal
📍 Ahmedabad