Director, Regulatory Affairs

Director Regulatory Affairs

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values\-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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.

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%).

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards \& Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives


• Health and wellbeing programmes including medical, dental, and vision coverage where applicable


• Retirement and pension plans


• Life assurance and disability coverage


• Employee assistance programmes and wellbeing resources


• Learning and development opportunities through structured training and career pathways

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

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