Regulatory Submissions Manager
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring recent 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
- Strong 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 & Benefits
ICON offers a competitive and comprehensive total rewards package designed to suppor