Senior Director, Regulatory Affairs

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.

Responsibilities

• 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

Requirements

• 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