ICON plc
Director, Regulatory Affairs
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Director, Regulatory Affairs
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.
As a Director, Regulatory Affairs at ICON, you will ensure compliance with regulatory requirements and provide strategic direction to ICON’s customers in both pharma and small biotechs.
What You Will Do
You will lead regulatory affairs activities, actively partner with subject matter experts across projects, and provide strategic direction while guiding multidisciplinary teams to deliver high-quality regulatory deliverables aligned with business and customer objectives. Key responsibilities include:
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Driving Strategic Development Collaborating with internal and external teams to define and develop robust regulatory strategies using Target Product Profiles (TPPs) and Clinical Development Plans (CDPs) to achieve broader development goals.
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Leading Submissions & Lifecycle Management Overseeing the development, hands-on authoring, and submission management of regulatory documents, including:
- Initial European Marketing Authorisation Applications (MAAs) (CP, MRP, or DCP).
- Post-licensing lifecycle management activities.
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Navigating European Pathways Managing complex pre-marketing designation submissions in Europe, with expertise in:
- Orphan Drug Designations
- Paediatric Investigation Plans (PIPs)
- PRIME (Prioritisation of Medical Innovations) schemes
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Leading Agency Interactions Acting as the primary point of contact for regulatory agencies, including:
- Leading Scientific Advice meetings
- Coaching and training customer or internal Subject Matter Experts (SMEs) to maximise meeting outcomes.
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- Providing Regulatory Intelligence & Insights
Interpreting and applying relevant legislation and guidelines to:
- Drive informed decision-making.
- Enhance stakeholder relationships with regulatory agencies.
Your Profile
You must possess 10-12 years of combined industry or consulting experience in regulatory affairs, with a proven track record in high-performing teams and a commitment to delivering impactful results.
Required Qualifications & Experience
Education
- A Bachelor’s degree in a science-related discipline or healthcare-related field; a Master’s/MSc or PhD preferred.
Industry Experience
- Extensive regulatory affairs experience in the pharmaceutical or clinical research industry.
- Hands-on management of European regulatory submissions (CP/DCP) and post-authorisation activities.
- Strong preference (but not essential) for experience in advanced therapy medicinal products (ATMPs) or international markets.
Technical & Strategic Skills
- Expertise in designing regulatory strategies (TPPs, CDPs).
- Ability to author and manage regulatory submissions independently.
- Self-sufficiency in technical document writing and submission workflows.
Leadership & Collaboration
- Strong leadership skills to guide cross-functional teams and manage complex projects.
- Exceptional ability to work collaboratively in a dynamic environment.
Communication & Stakeholder Management
- Exceptional interpersonal skills and stakeholder influence.
- Proven ability to negotiate with regulatory agencies and drive strategic change.
Travel Requirements
- Willingness to travel approximately 25% of the time.
What ICON Can Offer You
Our success depends on the talent and quality of our people. We’ve made it a priority to create a diverse, inclusive culture that recognises and rewards performance while championing development.
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Core Benefits Include
- Annual leave entitlements fit for your role and location.
- A tailored range of health insurance options for you and your family.
- Competitive retirement planning tools to maximise savings.
- Access to LifeWorks, a Global Employee Assistance Programme offering 24/7 wellbeing support via 80,000 specialists.
- Life assurance cover for your family.
- Flexible perks including:
- Childcare vouchers
- Battery/bike purchase schemes
- Discounted gym memberships
- Subsidised transport options
- Health assessments
To learn more about all benefits offered at ICON, visit our [Careers website].
ICON’s Commitment to Diversity & Inclusion
At ICON, inclusion and belonging are central to our mission. We strive to provide an accessible, welcoming workplace for all employees and applicants, fostering equality and eliminating discrimination.
As part of our commitment:
- All qualified applicants will receive equal consideration, regardless of race, religion, sex, sexual orientation, gender identity, national origin, disability status, or veteran status.
- Working with any disabilities? ICON is ready to accommodate appropriate adjustments—whether during application or interview processes. Please inform us directly or submit a request [here].
Still unsure whether you meet all requirements? We highly encourage you to apply! There’s a high chance you might resonate with the ICON culture or be suited for other open roles within the organisation.
Already an ICON Employee?
[Click here to apply] directly
Note: ICON does not discriminate based on protected attributes.
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