Regulatory Scientist

ICON Clinical Research; Bogotá ciudad; Presencial; 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

Colombia

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements

• A range of health insurance offerings to suit you and your family’s needs.

• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations)