Senior Director, Regulatory Affairs

Senior Director, Regulatory Affairs

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 Director, Regulatory Affairs at ICON, you will provide strategic direction and management of Regulatory Affairs teams (up to 80 team members) and projects and contribute to the strategic direction and overall management of the Regulatory Affairs function at ICON strategic solutions.

What You Will Do:

Your focus will be on driving regulatory affairs performance, ensuring quality, and building capability across your area.

Key responsibilities include:

• Lead and oversee the regulatory affairs strategy for ICON's therapeutic area teams as a departmental leader, set a clear and convincing future direction, while communicating with clarity.
• Collaborate with cross-functional teams to develop comprehensive regulatory plans and submissions
• Provide expert guidance on regulatory requirements and ensure adherence to global regulations
• Prepare and/or support proposals and bids and attend client bid defense meetings; participate in Triage meetings as required
• Represent ICON in interactions with regulatory authorities, presenting data and addressing inquiries
• Mentor and develop a team of regulatory affairs professionals, fostering their growth and expertise
• Represent the Regulatory Affairs Department in Business Development activities and generate new business opportunities.
• Energizing & Developing Others: Creating an environment that motivates people; Identifies development opportunities for self and others; act as a coach and mentor and share expertise.
• Commercial Awareness: Understanding the ICON business globally; Controls costs and maximizes revenues, margins and added value; Promotes ICON effectively in all interactions.

Your Profile:

You will bring significant regulatory affairs experience, with a track record of building high-performing teams and delivering results.

Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field; advanced degree preferred
• Extensive experience in regulatory affairs, with a proven track record in leading global submissions
• In-depth knowledge of regulatory guidelines, ICH/GCP, and industry best practices
• Strong analytical and problem-solving skills, with the ability to navigate complex regulatory landscapes
• Excellent communication and negotiation abilities, with the capacity to convey regulatory strategies effectively
• Willingness to travel as required (approximately 25%)

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