Description
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, Pharmacovigilance, and Manufacturing teams.
- Ensure dossier compliance with WHO, ICH, and local authority guidelines.

2. Regulatory Strategy & Market Support
- Develop registration strategies for RoW markets considering country‑specific regulations.
- 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.

5. Compliance & Intelligence
- Monitor regulatory guideline updates for RoW markets.
- Ensure submissions comply with the latest country requirements.
- Support internal audits, regulatory inspections, and due‑diligence audits.

6. Team & Project Coordination
- Mentor junior team members and review their regulatory work.
- Track regulatory milestones and ensure alignment with project timelines.
- Participate in cross‑functional meetings for project planning and risk assessment.

Markets Typically Covered (RoW)
- LATAM: Brazil, Mexico, Colombia, Peru, Chile, Guatemala
- MENA/GCC region
- CIS: Russia, Ukraine, Kazakhstan,etc.
- ASEAN: Philippines, Vietnam, Thailand, Malaysia

Qualifications
Required Qualifications & Experience
- Educational Background:
- M.Pharm / B.Pharm
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📌 Assistant Manager, Regulatory Affairs (Ahmedabad)
🏢 Amneal
📍 Ahmedabad