Executive, Regulatory Affairs

Amneal Pharmaceuticals · Ahmedabad

  • Experience3–9 yrs
  • SalaryNot disclosed
  • Work modeonsite
  • Levelmid
  • Posted11 Sept 2026
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About Amneal Pharmaceuticals

Amneal Pharmaceuticals is hiring in Ahmedabad in pharma biotech. This role looks for around 3+ years of experience.

Skills

  • Pharmaceutical Regulatory Affairs
  • CTD
  • ACTD
  • WHO guidelines
  • ICH guidelines
  • Regulatory compliance
  • Regulatory strategy
  • Regulatory lifecycle management
  • CMC variations
  • Health authority interaction

The role

A regulatory affairs executive at a pharmaceutical company prepares pharmaceutical regulatory submissions, manages regulatory compliance, and handles pharmaceutical lifecycle management. The role coordinates dossiers, responds to health authorities, and monitors regional requirements.

Full job description

Key Responsibilities

JOB DESCRIPTION

Dossier Preparation & SubmissionsPrepare, review, and submit CTD / ACTD / country‑specific dossiers for:New product registrationsLine extensions (strength, pack size, shelf life)Variations and renewalsCoordinate 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. Regulatory Strategy & Market SupportSupport business development by providing regulatory feasibility and timelines for new markets/products.Assess regulatory impact for formulation/site changes. Regulatory Lifecycle ManagementManage post‑approval changes, including:CMC variationsLabeling updatesArtwork changesTrack and ensure timely renewals/re‑registrations.Maintain approved product documentation and regulatory databases. Health Authority InteractionHandle 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. Compliance & IntelligenceMonitor regulatory guideline updates for RoW markets.Ensure submissions comply with the latest country requirements.

Markets Typically Covered (RoW)

LATAM: Brazil, Mexico, Colombia, Peru, Chile, GuatemalaMENA/GCC regionCIS: Russia, Ukraine, Kazakhstan, etc.ASEAN: Philippines, Vietnam, Thailand, Malaysia, etc.

Qualifications

Required Qualifications & Experience

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