Senior Global Regulatory Scientist

Regulatory Scientist / Senior Regulatory Scientist / Sofia / Warsaw

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.

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

What You Will Do:

You will take responsibility for regulatory affairs deliverables, applying your skills to ensure quality and efficiency.

Key responsibilities include:

• Contributing to regulatory strategy development for clinical programmes, including plans for health authority interactions and submissions.

• Preparing, reviewing, and coordinating regulatory documents such as clinical trial applications, briefing packages, and responses to health authority questions.

• 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 programmes and submissions.

• Supporting regulatory interactions and meetings, including preparation of materials and documentation of outcomes.

Your Profile:

You will bring relevant regulatory affairs experience, along with the following qualifications and skills.

Required qualifications and experience:

• 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 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.

• Willingness to travel as required (approximately 5%)

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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

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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