Key Responsibilities
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.

--------------------------------------------------------------------------------
Regulatory Strategy & Market Support
Support business development by providing regulatory feasibility and
timelines for recent markets/products.
Assess regulatory impact for formulation/site changes.

--------------------------------------------------------------------------------
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.





--------------------------------------------------------------------------------
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.

--------------------------------------------------------------------------------
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 (India)
🏢 Amneal
📍 India