ICON plc
Senior Director, Regulatory Affairs
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Senior 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 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.
What You Will Do:
Your focus will be on driving regulatory affairs performance, ensuring quality, and building capability across your area. Key responsibilities include:
- 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
Your Profile:
You will bring significant regulatory affairs experience, with a track record of building high-performing teams and delivering results.
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Required qualifications and experience:
- 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:
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:
- 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
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Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee?
Please click here to apply
ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live.
If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
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