Director, Regulatory Affairs

Director, Regulatory Affairs

ICON

Multiple Locations

As a 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.

Key Responsibilities and accountabilities:

• 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.

Knowledge/Skills/Attributes:

• 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.

Education/Experience:

• 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.