Executive, Regulatory Affairs

About this role

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What you'll do

• 1. 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, 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.

Who can apply

• Educational Background:
• o M.Pharm / B.Pharm
• o 3-9 years in Pharmaceutical Regulatory Affairs

About Amneal India

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