Regulatory Scientist

Icon; Bogotá ciudad; Ibrido; COP 194.200.000 - 291.300.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Competitive salary

Descrizione del lavoro

ICON plc in Bogotá, Colombia, seeks a Regulatory Scientist for a hybrid role (office 3 days/wk) to support regulatory submissions and clinical research activities. You will ensure timely compliance with local and global regulations, interact with Health Authorities and Ethics Committees, and collaborate across Clinical Operations and Safety to advance trial programmes.

The ideal candidate has life sciences background, regulatory experience in CRO/pharmaceutical settings, strong English

Competenze

• Bachelor-level degree in a life science field and regulatory experience.
• Experience regulating clinical trial submissions to Health Authorities and Ethics Committees.
• Strong scientific, analytical, and organizational skills with attention to detail.
• Fluent English communication (written and spoken).

Mansioni

• Prepare, review, and coordinate regulatory documentation and submission packages per local and global requirements.
• Ensure regulatory deliverables are completed on time, within budgets and quality standards.
• Track submission documentation in CTMS, eTMF, and other regulatory systems.
• Collaborate cross-functionally to support clinical research programmes and submission strategies.
• Monitor regulatory changes and advise on impact to submissions and study execution.
• Support agency and Ethics Committee interactions, including briefing materials and meeting documentation.

Formazione

Degree in Life Sciences, Pharmacy, Biotechnology, or related scientific field

Strumenti

CTMS

eTMF

Regulatory submissions

Descrizione del lavoro

Office hybrid / 3 days at office.

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.

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 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