Director, Regulatory Affairs
Location: Remote - EU or UK
ICON plc is a world‑leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment that drives innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Due to a number of exciting new projects being awarded to ICON, we are expanding our team and expertise with the recruitment of a Director of Regulatory Affairs within our global Regulatory Consulting Solutions (RCS) team.
Key Responsibilities and accountabilities
Act as a regulatory subject‑matter expert for ICON and support initiatives to ensure awareness of new regulatory requirements and opportunities.
Provide strategic regulatory advice in response to client queries, leveraging deep experience from interacting with health authorities and collaborating with internal experts.
Manage client engagements by understanding and prioritising objectives, establishing timelines, estimating costs and overseeing contract execution across multiple regions for all regulatory services.
Conceptualise and draft complete proposals based on a client idea or RFP, including independent development of scientific content and project plans, with strong conversion rates from proposal to award.
Prioritise and deliver across multiple projects within established timeframes and budgets, ensuring high‑quality strategic and operational output.
Serve as the primary liaison with health authorities for designated projects.
Act as a scientific thought partner to clients and internal teams, ensuring alignment with global regulatory expectations.
Train, coach, and develop team members to strengthen global regulatory expertise across the RCS organisation.
Actively contribute to the demonstration of ICON’s regulatory capabilities through thought leadership, such as contributing to articles and external presentations.
Knowledge, Skills & Attributes
Leading EMA scientific advice interactions, including early development consultations and training clients in health‑authority interactions.
Experience with common European regulatory procedures such as Paediatric Investigation Plans, Orphan Drug Designations, PRIME, etc.
Experience contributing to Marketing Authorization Applications (MAA) with EMA or national health authorities in Europe and the UK.
Strong post‑market regulatory experience supporting lifecycle management across Europe, the UK and other regions.
Experience in regulatory writing and dossier preparation, including meeting packages, scientific advice briefing books and global submission components.
Expertise across multiple product modalities (small molecules, biologics, gene therapies, cell therapies) and ideally across more than one therapeutic area.
Excellent verbal and written communication skills: conveys thoughts clearly, concisely and accurately, using appropriate regulatory, medical and scientific nomenclature.
Advanced planning and organisational skills with the ability to manage complex global programmes and competing priorities. High attention to detail and ability to resolve discrepancies across diverse regulatory and scientific documents.
Demonstrates an ability to lead or contribute to departmental continuous process and service improvement or other initiatives.
Prior experience in client interaction and/or a consulting environment is advantageous.
Education & Experience
Bachelor’s degree in a relevant discipline, preferably life sciences or another healthcare field.
Advanced degree (MSc., PhD., M.D., Pharm.D, MBA) in a biological, medical, chemical or engineering field may be beneficial.
Minimum of 15 years of related experience in Regulatory Affairs, in Pharma or CRO, with emphasis on EU Regulatory Affairs.
Experience supporting client development activities and people management.
What ICON can offer you
We offer a competitive salary and a range of additional benefits designed to be competitive within each country and focused on well‑being and work‑life balance.
Various annual leave entitlements.
Health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings.
Global Employee Assistance Programme (TELUS Health) – 24‑hour access to a global network of professionals for you and your family’s well‑being.
Life assurance.
Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes and health assessments.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process or to perform the essential functions of the position, please let us know or submit a request here.
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