Senior Director, Regulatory Affairs

ICON plc

2d

About The Position

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 Senior Director, Regulatory Affairs at ICON, you will develop and execute regulatory strategies, ensuring compliance with global regulations, and facilitate the successful submission and approval of clinical development programs. Your focus will be on driving regulatory affairs performance, ensuring quality, and building capability across your area.

Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field; advanced degree preferred
• Extensive experience in regulatory affairs, with a proven track record in leading global submissions
• In-depth knowledge of regulatory guidelines, ICH/GCP, and industry best practices
• Strong analytical and problem-solving skills, with the ability to navigate complex regulatory landscapes
• Excellent communication and negotiation abilities, with the capacity to convey regulatory strategies effectively
• Willingness to travel as required (approximately 25%)
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Nice To Haves

• advanced degree preferred

Responsibilities

• Lead and oversee the regulatory affairs strategy for ICON's therapeutic area teams
• Collaborate with cross-functional teams to develop comprehensive regulatory plans and submissions
• Provide expert guidance on regulatory requirements and ensure adherence to global regulations
• Represent ICON in interactions with regulatory authorities, presenting data and addressing inquiries
• Mentor and develop a team of regulatory affairs professionals, fostering their growth and expertise

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: Senior