Amneal Pharmaceuticals, Inc. is a global pharmaceutical company. Our team of 7,500+ colleagues helps make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of 270+ high- quality medicines.
Post : Executive, Regulatory Affairs
Job Description
1. Dossier Preparation & Submissions
• Prepare, review, and submit CTD / ACTD / country specific dossiers for:
o New product registrations
o Line extensions (strength, pack size, shelf life)
o 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.
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.
3. Regulatory Lifecycle Management
• Manage post approval changes, including:
o CMC variations
o Labeling updates
o 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 whenever required.
5. Compliance & Intelligence
• Monitor regulatory guideline updates for RoW markets.
• Ensure submissions comply with the latest country requirements.
Additional Information
Experience : 3-9 years in Pharmaceutical Regulatory Affairs
Qualification : B.Pharm, M.Pharm
Location : Ahmedabad City, Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th October 2026
Regulatory Affairs Executive : Apply Online
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