ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Manager, Regulatory Affairs to join our diverse and dynamic team. As a Manager, Regulatory Affairs at ICON, you will play a pivotal role in contributing to drug development as part of the Regulatory Affairs team. You'll provide regulatory guidance and operational support across various stages of drug development, including early development, agency interactions, clinical trial applications, marketing applications, and post-approval staff.
What You Will Be Doing
Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA
Provide regulatory guidance and efforts to internal teams
Participate in agency interactions and regulatory submissions
Contribute to developing best practices within ICON Regulatory Affairs through your insight of regulatory processes and guidelines
Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature
Your profile
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 biotechNlogy industry
Prior 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
What ICON Can Offer You
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of extra benefits. Our benefits are designed to be competitive within each country