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Regulatory Scientist

icon · Bogota

New
Hybrid 🇬🇧 English
CTMS eTMF

Job description

About the role

ICON is seeking a Regulatory Scientist to support regulatory submissions and clinical research activities in Bogota, Colombia. The role is hybrid, requiring three days per week on‑site.

Key responsibilities

  • Prepare, review and coordinate regulatory documentation and submission packages in line with local and global requirements.
  • Track and maintain submission and approval records in CTMS, eTMF and other regulatory systems.
  • Collaborate with Clinical Operations, Study Start‑Up, Safety and other teams to support trial execution.
  • Monitor regulatory changes and advise on their impact.
  • Support interactions with Health Authorities and Ethics Committees, including briefing materials and meeting documentation.

Required profile

  • Degree in Life Sciences, Pharmacy, Biotechnology or related field.
  • Experience in Regulatory Affairs within clinical research, CRO, biotech or pharma.
  • Strong knowledge of local and global regulatory requirements for clinical trials.
  • Excellent written and verbal communication skills in English.

Required skills

  • CTMS
  • eTMF

What we offer

  • Competitive base salary and performance incentives.
  • Health, dental and vision coverage.
  • Retirement and pension plans.
  • Life assurance and disability coverage.
  • Learning and development opportunities.

Questions fréquentes

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Source : ats:workday

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Published 16 hours ago

Expires 1 month from now

10 views · 0 interested

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