Officer/Executive - RA

47 minutes ago

Vapi, Gujarat, India Quality HR Services Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Responsibilities:

  • Compilation and review of regulatory dossiers (CTD, ACTD, eCTD) for CIS, LATAM (especially Brazil & Mexico), African, and EU regions.
  • Handle full lifecycle of product registration including new submissions, renewals.
  • Review technical documentation: PDR, DMF, AMV, BMR/BPR, Specifications, Stability Reports, BE Studies, etc.
  • Address Ministry of Health (MoH) queries and manage deficiency responses.
  • Manage post-approval changes and variation submissions.
  • Liaise with international regulatory agents and distributors for submission coordination.
  • Artwork review and approval ensuring compliance with label regulations.
  • Maintain up-to-date registration database and submission tracker.
  • Prepare administrative documents: POAs, LOAs, legalization support, etc.
  • Conduct compliance review for change controls, tech transfer documents, and CMO
  • Support site registration and GMP audits when required.
  • Review and finalize Quality Agreements with partners/clients.
  • Handle pharmacovigilance documentation (via third-party support).

Required Skills:

  • Expertise in CIS, LATAM, EU, and African regulatory landscapes.
  • Strong understanding of regulatory systems (e.g., ANVISA, EMA, CDSCO).
  • Prior QC/analytical lab experience (esp. with HPLC) is a plus.
  • Proficient in regulatory writing and dossier compilation independently.
  • Strong coordination, analytical, and document management skills

Required Qualification: - B.Pharm/M.Pharm

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