Director, Regulatory Affairs

Director, Regulatory Affairs

ICON

Reading, United Kingdom

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.

What You Will Do:

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.

Required qualifications and experience:

• 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%).