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 global 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, biotechnology, or pharmaceutical environments.
• Strong experience managing clinical trial submissions to Health Authorities and Ethics Committees.
• Good understanding of local and global regulatory requirements related to clinical research and clinical development.
• Experience working with CTMS, eTMF, or similar regulatory systems.
• Strong scientific, analytical, and organizational skills with high attention to detail.
• Ability to manage multiple regulatory activities and timelines in a fast-paced environment.
• Excellent written and verbal communication skills.
• Fluent English communication skills (written and spoken).

Preferred Qualifications:

• Experience supporting global or regional clinical trial submissions.
• Knowledge of regulatory processes in Colombia and LATAM markets.
• Understanding of study start-up activities and regulatory strategy development.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply