ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring current 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.
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
Robust understanding of global regulatory requirements and guidelines
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Perks
ICON offers a competitive and comprehensive total rewards package designed to supp