Director, Regulatory Affairs

As a Director, Regulatory Affairs at ICON, you will ensure compliance with regulatory requirements and provide strategic direction to ICON's customers both in pharma and small biotechs., You will lead regulatory affairs activities and actively partner with subject matter experts across projects, providing strategic direction while guiding multidisciplinary teams to ensure the delivery of high-quality regulatory deliverables in alignment with business and customer objectives. Key responsibilities include:

• 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. This includes overseeing initial European Marketing Authorisation Applications (MAAs - CP, MRP, or DCP) as well as post-licensing lifecycle management.
• Navigating European Pathways : Managing complex pre-marketing designation submissions in Europe, with specific 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 : Overseeing the interpretation of relevant legislation and guidelines to drive informed decision-making and establish strong partnerships with regulatory agencies.
Your Profile: You will bring significant regulatory affairs experience developed across 10-12 years of industry and/or consulting roles, with a track record of working in high-performing teams and delivering results.


• Education : At least a Bachelor's degree in a relevant scientific discipline or healthcare-related field; advanced degree preferred.
• Experience : Extensive experience in regulatory affairs within the clinical research or pharmaceutical industry, with a proven history of managing European regulatory procedures (CP/DCP) and post-authorization activities. Candidates with advanced therapy or international market experience are particularly welcome although this is not essential.
• Strategic & Technical Ability : Deep expertise in developing regulatory strategies (TPPs, CDPs), combined with self-sufficiency in technical document writing and submission management.
• Leadership Skill : Strong leadership skills and a proven ability to manage 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%).
  
  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.
  
  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.