Covance

  • Companion Diagnostics ( CDx ) Regulatory Affairs Manager

    Job Location(s) US-NC-Raleigh-Durham | US-NC-Research Triangle Park | US-NC-Morrisvill
    Job Number
    2017-16336
    Job Category
    Scientific Bachelor's Degree
    Position Type
    Full-Time
  • Job Overview

    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

     

    Why Covance

     

    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.

     

     

    Education/Qualifications

    • Bachelor’s degree in a science discipline with a preference for an advanced degree

     

    Experience

    • 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

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