Senior Executive, Regulatory Affairs at Amneal… · Ahmedabad…

Key Responsibilities

1. Dossier Preparation & Submissions

• Prepare, review, and submit CTD / ACTD / country‑specific dossiersfor:
  • 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.

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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.

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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.

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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.

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5. Compliance & Intelligence

• Monitor regulatory guideline updates for RoW markets.
• Ensure submissions comply with the latest country requirements.

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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: o M.Pharm / B.Pharm • Experience: o 7-9 years in Pharmaceutical Regulatory Affairs