Regulatory Scientist
icon · Bogota
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.
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Published 16 hours ago
Expires 1 month from now
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