PRAHS

  • Director / Associate Director, Regulatory Strategist (Home Based)

    Job Locations (All) | US-Remote
    Posted Date 1 week ago(12/6/2018 3:51 PM)
    ID
    2018-50335
  • Overview

    Director Level Position in the Regulatory Strategy & Agency Liaison team, Global Regulatory Affairs

    We are looking for US Regulatory subject matter experts and FDA liaison for assigned development projects that will execute and lead NDA/BLA/MAA regulatory activities.

     

    PRA Health Sciences is a Clinical Research Organization experiencing exceptional growth globally. The people we employ are key to this growth.

     

    People don’t come to PRA to witness the future of clinical development, they come to shape it. With an average of more than 6 former employees returning to PRA each month we can confidently say that the grass is greener at PRA. Come and apply if you'd like the opportunity to work alongside regulators in our Regulatory Strategy and Agency Liaison team that have the depth and diversity of experience to impact healthcare for the better.

    Join the movement and discover your passion, your purpose, your PRA.

    Responsibilities

    Position overview:

     

    • Develops and leads the execution of regulatory strategic development and registration strategies as the regulatory affairs (RA) Strategy & Agency Liaison member on multi-function project teams for assigned products throughout clinical development and commercial lifecycle.
    • Develops comprehensive understanding of global RA strategy regulations and guidelines and applies that knowledge to enhance probability of regulatory success or enhancing regulatory compliance.
    • Successfully communicates and negotiates with international Health Authorities as necessary, directly and indirectly.
    • Responsible for the compilation of Agency submissions for regulatory pathways including but not limited to clinical development, marketing authorizations, product variations and renewals of international medicinal products.

    Qualifications

    What are we looking for?

     

    • You have minimum bachelor’s degree
    • You have minimum 14-20 years’ relevant experience
    • You will have demonstrable Regulatory Affairs experience in drug development and registration activities.
    • You will be well versed in leading and providing regulatory input to cross functional project teams.
    • You are experienced in developing and executing regulatory strategies.
    • A team focused, and global approach is vital along with the ability to travel.
    • You have hands-on execution experience leading NDA/BLA development, submission, and FDA negotiation through approval.
    • Ability to travel 20-30%

    Position is based anywhere in the US

    Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

    Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.

     

    PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.

     

    For more information please visit our website: www.prahs.com

     

    To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status


    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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