Regulatory Scientist

About the role

Regulatory Scientist

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.

As a Regulatory Scientist at ICON, you will support the development, implementation, and execution of regulatory strategies for clinical development programs.

What You Will Do:

• Preparing, reviewing, and coordinating regulatory documents such as clinical trial applications, briefing packages, and responses to health authority questions.
• Contributing to regulatory strategy development for clinical programs, including plans for health authority interactions and submissions.
• Interpreting and applying relevant regulations, guidelines, and precedents to support compliant study design and execution.
• Collaborating with clinical, safety, CMC, and other cross-functional teams to ensure alignment of regulatory content and messaging.
• Monitoring changes in the regulatory environment and providing guidance on potential impact to programs and submissions.
• Supporting regulatory interactions and meetings, including preparation of materials and documentation of outcomes.

Your Profile:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Experience in regulatory affairs, regulatory writing, or clinical development within the pharma, biotech, or CRO industry.
• Good understanding of global regulatory frameworks and guidelines relevant to clinical development.
• Strong scientific, analytical, and critical thinking skills, with the ability to interpret complex data and regulations.
• Excellent English - written and verbal communication skills, with high attention to detail and accuracy.
• Ability to work effectively in cross-functional teams and manage multiple regulatory activities and timelines.

Location: Buenos Aires

Reference: JR161625

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.

At ICON, inclusion and 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.

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

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Location details and other roles are listed on the ICON careers site.