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
Job Summary
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.
ICON offers a range of benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.
At ICON, inclusion & belonging are fundamental to our culture and values, and the company is committed to providing a workplace free of discrimination and harassment.
Matching Summary
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.
Skills & Requirements
Must-have
Regulatory submissions CTA/IND/MAA
Lead regulatory activities independently
Global regulatory requirements knowledge
Preparation of core regulatory packs Canada
Regulatory guidance to internal teams
Nice-to-have
Experience with Companion diagnostics
IVDR submissions knowledge
Clinical performance studies experience
Collaborative cross-functional teamwork
Inclusive and diverse work culture
Key Requirements
Bachelor's degree scientific or healthcare field
Minimum 6 years regulatory affairs experience
Experience in pharmaceutical or biotechnology industry