Senior Director, Regulatory Affairs
ICON · Reading, UK +1 more
RegulatoryFull-timeCompany career page
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Role summary
Senior Director, Regulatory Affairs position leading teams of up to 80 professionals across regulatory strategy, global submissions, and compliance for a clinical research organization. Requires extensive regulatory experience, advanced degree preferred, and expertise in ICH/GCP guidelines with ability to represent the organization before regulatory authorities and manage cross-functional projects.
What they're looking for
- Bachelor's degree in scientific or healthcare-related discipline; advanced degree preferred
- Extensive regulatory affairs experience with proven track record leading global submissions
- In-depth knowledge of regulatory guidelines, ICH/GCP, and industry best practices
- Strong analytical and problem-solving skills navigating complex regulatory landscapes
- Excellent communication and negotiation abilities conveying regulatory strategies effectively
- Demonstrated experience building and managing high-performing teams
- Willingness to travel approximately 25% as required
What you'll be doing
- Lead regulatory affairs strategy for therapeutic area teams and set departmental direction
- Oversee regulatory affairs teams up to 80 members and manage projects
- Collaborate cross-functionally to develop comprehensive regulatory plans and submissions
- Represent ICON in regulatory authority interactions and bid defense meetings
- Mentor and develop regulatory affairs professionals; identify growth opportunities
Privacy & handoff
This role links to ICON's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.