PRAHS

  • Associate Regulatory Submission Manager (Boston preferred)

    Job Locations (All) | US-MA-Boston
    Posted Date 6 days ago(11/7/2018 3:06 PM)
    ID
    2018-49583
  • Overview

    Do you want to watch clinical development change, or do you want to be the one to shape it?

     

    Because we’re hoping you’re here for the latter.

     

    Who are we?

    We Are PRA.

     

    We are 15,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.

     

    Who are you?

    You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be an Associate Global Submission Manager you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

     

    Still here? Good. Because if this is you, we’d really like to meet you.

    Responsibilities

    What will you be doing?

     

    As an Associate Global Submission Manager, you will effectively works with global/regional cross functional teams to plan, prepare and deliver compliant regulatory submissions. The aSM introduces flexibility within and across therapeutic areas and marketed products to provide broad regulatory submission support to ensure all submission and business deliverables are met in a timely manner. With support from the Global Submissions Manager Lead (GSM) or Line Manager and in collaboration with key members from regulatory affairs, the aSM will compile and execute submission strategy plans for new marketing authorizations as well as submission strategies for the maintenance of existing drug licenses.

    Qualifications

    What do you need to have?

     

    Associate Global Submission Manager:

     

    Education:  Bachelor’s degree (or significant proven experience in a pharmaceutical environment) OR Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write and speak fluent English and host country language.

    Skills: 

    • 3-5 years experience working within a Regulatory or Project Management environment.
    • Proven experience in developing and implementing novel technological solutions and processes.
    • Solid understanding of document management systems and concepts highly preferred
    • Demonstrable experience of multitasking in a deadline controlled and preferably highly regulated environment
    • Qualified project management experience
    • Experience of introducing new systems and procedures based on interpretation and application of regulatory agency guidance documents and mandated legislation.
    • Familiar with the drug development process and evidence of working with Regulatory Agencies supporting regulatory dossier submission, review and approval processes
    • Solid understanding of document management systems and concepts
    • 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.

    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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