Regulatory Scientist – LATAM Submissions & Strategy

ICON Clinical Research; Bogotá; Híbrido; COP 90.000.000 - 140.000.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual leave

Health insurance

Retirement planning

LifeWorks program

Life assurance

Flexible country-specific benefits

Descripción de la vacante

ICON plc, a world-leading healthcare intelligence and clinical research organization, seeks a Regulatory Scientist to support regulatory submissions in Colombia. This hybrid Bogotá-based role focuses on ensuring compliant and timely submissions to Health Authorities and Ethics Committees to advance clinical development programs.

You will prepare and coordinate documentation, track submissions in CTMS/eTMF, collaborate with Clinical Operations and Safety, and monitor regulatory changes to guide

Formación

• Degree in Life Sciences, Pharmacy, Biotechnology, or related field.
• Experience in Regulatory Affairs within clinical research, CRO, biotech, or pharma.
• Experience managing clinical trial submissions to Health Authorities and Ethics Committees.
• Understanding of local and global regulatory requirements for clinical research.

Responsabilidades

• Prepare, review, and coordinate regulatory documentation and submission packages per local/global requirements.
• Ensure regulatory deliverables meet timelines, budgets, and quality standards while complying with regulations and ICH-GCP.
• Track and maintain submission documentation within CTMS, eTMF, and other systems for accuracy.
• Collaborate cross-functionally with Clinical Operations, Study Start-Up, Safety, and other teams to support submission strategies.
• Monitor regulatory landscape changes and advise on their impact on submissions and study execution.
• Support interactions with agencies and Ethics Committees, including briefing materials and meeting documentation.

Conocimientos

Regulatory affairs

Clinical submissions

CTMS/eTMF experience

English proficiency

Communication skills

Analytical skills

Educación

Degree in Life Sciences/Pharmacy/Biotechnology

Herramientas

CTMS

eTMF

Descripción del empleo

ICON plc, a world-leading healthcare intelligence and clinical research organization, seeks a Regulatory Scientist to support regulatory submissions in Colombia. This hybrid Bogotá-based role focuses on ensuring compliant and timely submissions to Health Authorities and Ethics Committees to advance clinical development programs.

You will prepare and coordinate documentation, track submissions in CTMS/eTMF, collaborate with Clinical Operations and Safety, and monitor regulatory changes to guide