Assistant Manager, Regulatory Affairs

Amneal Pharmaceuticals


Date: 4 hours ago
City: Ahmedabad, Gujarat
Contract type: Full time
Key Responsibilities

 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.
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
  • Experience:
    • 8–10 years in Pharmaceutical Regulatory Affairs

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