Companion Diagnostics (CDx) Regulatory Affairs Manager
Grow your career with an industry leader
Are you a strategic thinker who enjoys partnering with others? Are you process oriented and do you thrive in a regulated environment? Does cutting-edge science excite you?
If you are looking for a company where you can gain exposure to a wide variety of science and explore a multitude of career paths across the drug development spectrum, consider working at Covance as a CDx Regulatory Affairs Manager. In this position you will provide strategic and tactical support to the Companion Diagnostics Development and Operational Teams, working to execute the regulatory strategies, contribute to and at times lead FDA pre-submission package development and subsequent meetings, and co-author final product submissions. You will provide guidance to assure that all regulatory submissions are planned, communicated and executed per all appropriate regulatory and business requirements and serve as a subject matter expert regarding various regulations relevant to the diagnostic industry as you:
This position is based in our newly constructed Morrisville, NC Diagnostics Development facility.
Working and thriving at Covance
As part of the global Regulatory Affairs team, you’ll work in our fast-paced environment and contribute to our client-centric solutions in one the world's largest and most comprehensive drug development services companies.
We take care of you with a competitive compensation package with medical and dental insurance, tuition reimbursement, a 401(k) plan with a generous company match, along with short and long-term disability and life insurance.
Why CDx Regulatory Affairs Managers choose to work at Covance
Get to know Covance
Beyond excellent compensation and benefits as a CDx Regulatory Affairs Manager, joining Covance opens the door to many career opportunities. Learn about what’s possible for your career when a company truly invests in you at http://careers.covance.com/possibilities.html
At Covance, it’s our people that make us great – it’s what our clients, our partners and, most importantly, what our employees say. Here, you’ll have the opportunity to lead and nurture exceptional people with diverse viewpoints. You’ll discover your own extraordinary potential as you drive strategy and build an even stronger organization with industry leaders from early development to the clinic and beyond. Through your everyday work and an energized purpose, you’ll advance science and impact the lives of countless individuals.
Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients, our team—and you.
Ready to join us? Let’s get started.