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.

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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.

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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.





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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.

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5. Compliance & Intelligence

* Monitor regulatory guideline updates for RoW markets.
* Ensure submissions comply with the latest country requirements.

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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