Director, Regulatory Affairs

ICON plc • Burlington, PE

18h

About The Position

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 guide the strategic direction of regulatory submissions.

Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field; advanced degree preferred
• Extensive experience in regulatory affairs within the clinical research or pharmaceutical industry.
• Strong leadership skills and a proven ability to manage cross-functional teams in a collaborative environment.
• Expertise in regulatory submission processes and familiarity with global regulatory frameworks.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive change in a complex organization.
• Willingness to travel as required (approximately 25%)
• Having the legal right to work in the country where the role is based.

Nice To Haves

• Advanced degree preferred

Responsibilities

• Direct regulatory affairs activities, ensuring quality, efficiency, and alignment with business objectives.
• Lead the development and submission of regulatory documents to ensure timely approvals for clinical trials and products.
• Collaborate with internal teams to develop regulatory strategies and identify opportunities for regulatory compliance enhancements.
• Oversee the interpretation of regulatory guidelines to drive informed decision-making and support project objectives.
• Provide strategic guidance on regulatory pathways and ensure alignment with global regulatory requirements.
• Establish partnerships with regulatory agencies and external stakeholders to foster effective communication and collaboration.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director