Covance Companion Diagnostics ( CDx ) Regulatory Affairs Manager in NC, United States
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:
Execute on regulatory strategies in support of Companion Diagnostic programs
Assist in the development of clinical regulatory strategies with members of the CDx Regulatory Affairs team, reviewing and providing comments on protocols and development plans
Participate in the submission of key regulatory filings which may include facilitation and preparation of US regulatory Pre Submission documents, facilitation of FDA pre submission meetings, preparation of US regulatory submissions (PMA and 510(k)), and support of EU representatives as they create CE/IVD Technical Files
Communicate with and facilitate interaction with global regulatory agencies
Coordinate regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants, as needed, providing solutions based on your knowledge and industry experience as you
Develop and implement components of regulatory strategies for investigational and commercial drug products
Monitor changes to development plans and provide regulatory guidance to teams to bridge changes into the clinic
Communicate application progress to key internal and external stakeholders
Participate in business meetings with potential new external partners
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
Join a global company with many opportunities for career growth
Make a direct impact in healthcare and the lives of patients
Partner with and learn from supportive colleagues and industry leaders
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.
- Bachelor’s degree in a science discipline with a preference for an advanced degree
5 years of experience supporting regulatory strategies and FDA submissions for in vitro diagnostic (IVD) products with evidence of 510K or PMA submissions
Demonstrated experience in one or more phases of IVD product development including design control, regulatory package documentation, and GMP manufacturing
Advanced working knowledge of regulatory submissions or registrations and requirements of GxPs (GCPs, GLPs, GMPs)
Experience in and a strong familiarity with FDA, EMA, and ICH guidelines
Proven success in working in a regulated environment such as CLIA, CAP, or IVD manufacturing
Excellent communication and interpersonal skills with the ability to influence others with impact and excellent attention to detail
Experience working in companion diagnostics is highly preferred
Job Number 2017-16336
Job Category Scientific Bachelor's Degree
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.