Senior Director, Regulatory Affairs

Job title: Senior Director, Regulatory Affairs

About the Role ICON plc is a world-leading healthcare intelligence and clinical research organization. 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'll Do

• 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.

What We're Looking For

• Significant regulatory affairs experience, with a track record of building high-performing teams and delivering results.
• 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%).

Nice to Have

• Experience in Business Development activities or client-facing roles.
• Advanced degree or certifications in regulatory affairs (preferred).

Compensation & Benefits

• Competitive salary with focus on well-being and work-life balance.
• Various annual leave entitlements; range of health insurance offerings; retirement planning to maximize savings.
• Global Employee Assistance Programme, LifeWorks, with 24-hour access to a global network of professionals.
• Life assurance; flexible country-specific optional benefits (childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others).