Colombia
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Regulatory affairs with submissions in clinical trials. Hybrid role in Bogota, Colombia.
We are currently seeking a Regulatory Scientist to join our diverse and dynamic team. As a Regulatory Scientist at Icon plc you will play a key role in supporting regulatory submissions and clinical research activities in Colombia. This position is focused on ensuring compliant and timely submissions to Health Authorities and Ethics Committees to support clinical trial execution and product development programmes.
What You Will Be Doing:
Prepare, review, and coordinate regulatory documentation and submission packages in accordance with local and integral regulatory requirements.
Ensure all regulatory deliverables are completed within agreed timelines,
budgets, and quality standards while maintaining compliance with applicable regulations, ICH-GCP guidelines, policies, and procedures.
Track and maintain submission and approval documentation within CTMS, eTMF, and other regulatory systems, ensuring accuracy and completeness.
Collaborate cross-functionally with Clinical Operations, Study Start-Up, Safety, and other internal teams to support clinical research programmes and submission strategies.
Monitor changes in the regulatory landscape and provide guidance regarding their impact on clinical trial submissions and study execution.
Support regulatory agency and Ethics Committee interactions, including preparation of briefing materials, responses, and meeting documentation.
Your Profile:
Degree in Life Sciences, Pharmacy, Biotechnology, or related scientific field.
Previous experience in Regulatory Affairs within clinical research, CRO, biotechnol
📌 Regulatory Scientist (Bogotá)
🏢 Icon
📍 Bogotá