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Regulatory Affairs Analyst – 1‑Year Contract

Feuji · Cartago

🇬🇧 English
Veeva Regulatory SAP

Descripcion del puesto

About the role

The Regulatory Affairs Analyst will support regulatory activities for a diverse portfolio that includes medicines, medical devices, cosmetics, and nutritional supplements. Working closely with cross‑functional teams, the analyst ensures product registrations, launches, and lifecycle management comply with local and international regulations.

Key responsibilities

  • Manage regulatory activities for assigned product portfolios, ensuring compliance with applicable laws.
  • Prepare, review, and maintain regulatory dossiers, applications, registrations, renewals, and lifecycle documentation.
  • Support new product launches by identifying appropriate regulatory pathways and completing required documentation on time.
  • Verify that labeling, claims, advertising, and promotional materials meet regulatory and internal standards.
  • Monitor regulatory legislation changes and assess their impact on products and business operations.
  • Maintain accurate regulatory data in Veeva Regulatory, SAP, and other relevant systems.
  • Collaborate with Marketing, Sales, Supply Chain, Quality, Medical, Demand Planning, and Legal teams to provide regulatory guidance.
  • Assist with inspections, audits, self‑inspections, and compliance initiatives.
  • Build and sustain relationships with local regulatory authorities and external stakeholders.

Required profile

  • Previous experience or strong knowledge in Regulatory Affairs or regulatory compliance.
  • Familiarity with regulations governing medicines, medical devices, cosmetics, and nutritional supplements.
  • Experience preparing and maintaining regulatory documentation and product registrations.
  • Strong analytical, organizational, and problem‑solving abilities with high attention to detail.
  • Excellent written and verbal communication skills and ability to work with stakeholders at all levels.

Required skills

  • Veeva Regulatory
  • SAP

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Publicado hace 2 semanas

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