Assistant Manager, Regulatory Affairs
Amneal Pharmaceuticals
Date: 2 weeks ago
City: Ahmedabad, Gujarat
Contract type: Full time
Key Responsibilities
JOB DESCRIPTION
Required Qualifications & Experience
JOB DESCRIPTION
- Dossier Preparation & Submissions
- Prepare, review, and submit CTD / ACTD / country‑specific dossiers for:
- New 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.
- 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.
- 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.
- 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.
- 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.
- LATAM: Brazil, Mexico, Colombia, Peru, Chile, Guatemala
- MENA/GCC region
- CIS: Russia, Ukraine, Kazakhstan,etc.
- ASEAN: Philippines, Vietnam, Thailand, Malaysia
Required Qualifications & Experience
- Educational Background:
- M.Pharm / B.Pharm
- Experience:
- 8–10 years in Pharmaceutical Regulatory Affairs
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