Key Responsibilities

1.

Dossier

Preparation & Submissions

- Prepare, review, and submit CTD / ACTD / country‑specific dossiers for:
- Current 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.

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