Director, Regulatory Affairs

About the Role Director Regulatory Affairs at ICON leads regulatory affairs activities and provides strategic direction to ICON’s customers in pharma and small biotechs, ensuring regulatory compliance and delivery of high-quality regulatory deliverables. The role collaborates with subject matter experts across projects and guides multidisciplinary teams to align regulatory work with business and customer objectives. What You'll Do

• Driving Strategic Development: Collaborating with internal and external teams to define and develop robust regulatory strategies, utilizing Target Product Profiles (TPPs) and Clinical Development Plans (CDPs) to achieve broader development goals.
• Leading Submissions & Lifecycle Management: Directing the development, hands-on authoring, and submission management of regulatory documents, including initial European Marketing Authorisation Applications (MAAs - CP, MRP, or DCP) and post-licensing lifecycle management.
• Navigating European Pathways: Managing complex pre-marketing designation submissions in Europe, with expertise in Orphan Drug Designations, Paediatric Investigation Plans (PIPs), and PRIME.
• Leading Agency Interactions: Leading regulatory agency interactions from the front—including Scientific Advice meetings—while coaching and training customer or internal SMEs to achieve optimal meeting objectives.
• Providing Regulatory Intelligence & Insights: Interpreting relevant legislation and guidelines to drive informed decision-making and establish strong partnerships with regulatory agencies. What We're Looking For
• Education: At least a Bachelor's degree in a relevant scientific discipline or healthcare-related field; advanced degree preferred.
• Experience: 10-12 years of regulatory affairs experience in the clinical research or pharmaceutical industry, with proven history of managing European regulatory procedures (CP/DCP) and post-authorization activities. Advanced therapy or international market experience welcome but not essential.
• Strategic & Technical Ability: Deep expertise in developing regulatory strategies (TPPs, CDPs), with self-sufficiency in technical document writing and submission management.
• Leadership Skill: Strong leadership capabilities with a track record of managing cross-functional teams and complex projects in a collaborative environment.
• Communication: Excellent interpersonal, stakeholder management, and agency negotiation skills, with the ability to influence and drive change in a complex organization.
• Travel: Willingness to travel as required (approximately 25%). Nice to Have
• Advanced therapy or international market experience is welcome, though not essential. Compensation & Benefits
• Competitive salary and benefits designed to support well-being and work-life balance.
• Various annual leave entitlements.
• A range of health insurance offerings.
• Competitive retirement planning offerings to maximize savings.
• Global Employee Assistance Programme, LifeWorks, providing 24-hour access to a global network of professionals for well-being support.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.