Senior Director, Regulatory Affairs

Senior 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.

Due to a number of exciting new projects being awarded to ICON, we are seeking to expand our team and expertise with the recruitment of a Senior Director of Regulatory Affairs within our global Regulatory Consulting Solutions (RCS) team. We are looking for passionate, resilient, and inspiring individuals to join our group of regulatory strategists with experience of liaising with European, UK and other global health authorities.

RCS are a global team of regulatory strategists from pharma, CRO and agency backgrounds, with expertise in drug development, regulatory strategy and operational implementation. We deliver global strategic regulatory consulting across all phases of drug development through to post‑marketing.

As a Senior Director, Regulatory Affairs, you will be expected to contribute to our culture of strategic excellence, adding value to our business and meeting the needs of a diverse portfolio of global clients. Representing ICON as a Subject Matter Expert in global regulatory affairs, you will proactively communicate with our clients to determine their objectives; propose appropriate regulatory solutions which can be delivered within agreed timeframes; and, execute on their delivery. As a senior member of the RCS team, you will also lead strategic client engagement, supporting business development activities.

• 
  
• Act as a regulatory subject matter expert for ICON. Support initiatives to ensure ICON maintains awareness of new regulatory requirements and opportunities and can deliver services accordingly. Actively contribute to maintaining company awareness of new requirements and opportunities.
  
• Provide strategic regulatory advice in response to client queries, leveraging your deep experience from interacting with health authorities, and collaborating with internal experts as needed.
  
• Manage client engagements including understanding and prioritizing objectives, establishing timelines, estimating costs and overseeing contract execution across multiple regions for all regulatory services.
  
• Conceptualize and draft complete proposals based on a client idea or Request for Proposal (RFP), including independent development of scientific content and project plans, with strong conversion rates from proposal to award.
  
• Prioritize and deliver across multiple projects within established timeframes and budgets, ensuring high‑quality strategic and operational output.
  
• Function as primary liaison with health authorities for designated projects.
  
• Act as 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 organization.
  
• Actively contribute to the demonstration of ICON’s regulatory capabilities through thought leadership, such as contributing to articles and external presentations.
  

• 
  
• Leading EMA scientific advice interactions, including early development consultations. This may include training clients in the conduct of health authority interactions, leading and documenting health authority meetings.
  
• Experience with common European regulatory procedures such as to Paediatric Investigation Plans, Orphan Drug Designations, PRIME etc.
  
• Experience in contributing to Marketing Authorization Applications (MAA) with EMA or national health authorities in Europe and 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 including small molecules, biologics, gene therapies, and cell therapies and ideally across more than one therapeutic area.
  
• Excellent verbal and written communication: Conveys thoughts in a clear, concise, and accurate manner. Uses appropriate regulatory, medical, and scientific nomenclature. Listens carefully and asks questions when necessary to ensure understanding.
  
• Advanced planning and organizational skills with the ability to manage complex global programs and competing priorities. High attention to detail with the ability to identify and resolve discrepancies across diverse regulatory and scientific documents.
  
• Demonstrates an ability to lead or contribute to departmental continual process and service improvement or other initiatives.
  
• Prior experience in client interaction and/or in a consulting environment is advantageous.
  

• 
  
• Bachelor’s degree in a relevant discipline, preferably in life sciences, or other healthcare field.
  
• Advanced degree (MSc., PhD., M.D., Pharm.D, MBA) in the biological, medical, chemical or engineering field may be beneficial.
  
• Minimum of 15 years related experience in Regulatory Affairs setting, in Pharma or CRO, with emphasis on EU Regulatory Affairs.
  
• Experience supporting client development activities and people management.
  

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.
  

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 in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply.