PRAHS

  • Director / Sr. Director, Regulatory Strategist (Home Based)

    Job Locations (All) | US-Remote
    Posted Date 1 week ago(12/6/2018 4:14 PM)
    ID
    2018-50336
  • Overview

    We are looking for a US Regulatory subject matter expert and FDA liaison for assigned development projects that will provide expert regulatory strategic consulting to sponsor client companies and to PRA stakeholders.

     

    PRA Health Sciences is a Clinical Research Organisation 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:

    • The Regulatory Strategist will develop regulatory strategies for the development of new and existing pharmaceutical and biologics products, interpreting new or existing regulatory requirements relevant to assigned products and projects
    • The Regulatory Strategist will lead and provide regulatory input to cross-functional project teams providing expertise on standalone or multi service deliverables.
    • Contributes to RFP/RFI and represents GRA (Strategy &Liaison) at BDMs, client meetings, conferences.

    Qualifications

    What are we looking for?

     

    • You have atleast a bachelor’s degree.
    • You have minimum 17-20 years relevant experience
    • You can demonstrate 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 with all FDA procedures and pathways.
    • You ideally have experience with one or more of the following: cellular/gene therapy, rare disease, pediatric indication product development.
    • A team focused, and global approach is vital along with the ability to travel up to 40%

     Position is home based 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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