Key Responsibilities

JOB DESCRIPTION

- Dossier Preparation & Submissions
- Prepare, review, and submit CTD / ACTD / country‑specific dossiers for:

- Recent 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 SupportSupport business development by providing regulatory feasibility and timelines for new markets/products.Assess regulatory impact for formulation/site changes. Regulatory Lifecycle ManagementManage 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 InteractionHandle 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 & IntelligenceMonitor 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:
- M.Pharm / B.Pharm
- Experience:
- 3-9 years in Pharmaceutical Regulatory Affairs

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