About this role
About the Role ICON plc is a world-leading healthcare intelligence and clinical research organization. As a Manager, Regulatory Affairs at ICON, you will contribute to drug development by leading regulatory activities and providing regulatory guidance across multiple stages, including early development, agency interactions, clinical trial applications, marketing applications, and post-approval activities. You will work independently on submissions and collaboratively within cross-functional teams to shape regulatory strategy and best practices. What You'll Do
- Lead regulatory activities and submissions independently, with experience in CTA/IND/MAA
- Provide regulatory guidance to internal teams and support regulatory strategy
- Participate in agency interactions and regulatory submissions
- Contribute to developing best practices within ICON Regulatory Affairs through an understanding of regulatory processes and guidelines
- Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature What We're Looking For
- Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred
- Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotech industry
- Experience with various regulatory submissions, including CTA/IND/MAA
- Ability to lead internal teams and carry out regulatory activities independently
- Strong understanding of global regulatory requirements and guidelines Compensation & Benefits
- Competitive salary and benefits
- Various annual leave entitlements
- Health insurance offerings
- Competitive retirement planning offerings
- Global Employee Assistance Programme (LifeWorks) with 24-hour access to a global network of professionals
- Life assurance
- Flexible country-specific optional benefits (e.g., childcare vouchers, bike purchase schemes, gym discounts, subsidized travel passes, health assessments) Visit ICON careers site to read more about the benefits ICON offers.