Director Regulatory Affairs

Senior Regulatory Affairs, US

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.

We are currently seeking a Director, Regulatory Affairs to join our diverse and dynamic team. As a Director, Regulatory Affairs at ICON, you will play a pivotal role in ensuring compliance with regulatory requirements and guiding the strategic direction of regulatory submissions. You will contribute to the successful development and approval of innovative treatments and therapies through expert oversight of regulatory initiatives and collaboration with cross-functional teams.

What You Will Be Doing:

• Leading the development and submission of regulatory documents to ensure timely approvals for clinical trials and products.
• Collaborating with internal teams to develop regulatory strategies and identify opportunities for regulatory compliance enhancements.
• Overseeing the interpretation of regulatory guidelines to drive informed decision-making and support project objectives.
• Providing strategic guidance on regulatory pathways and ensuring alignment with global regulatory requirements.
• Establishing partnerships with regulatory agencies and external stakeholders to foster effective communication and collaboration.

Your Profile:

• Advanced degree in a relevant field such as life sciences, pharmacy, or regulatory affairs.
• Extensive experience in regulatory affairs within the clinical research or pharmaceutical industry.
• Strong leadership skills and a proven ability to manage cross-functional teams in a collaborative environment.
• Expertise in regulatory submission processes and familiarity with global regulatory frameworks.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive change in a complex organization.

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.

Salary range: $161,824.00-$202,280.00

Bonus, Com, Stock, Benefits & Disclaimer verbiage:
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.

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