PRAHS

  • Senior Manager, Regulatory Affairs CMC - Home Based

    Job Locations - | US-Remote
    Posted Date 1 month ago(3/21/2018 9:50 PM)
    ID
    2018-45657
  • 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 a Senior Manager, Regulatory Strategy CMC, 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 a Senior Manager, Regulatory Strategy CMC, you will develops and leads the execution of regulatory CMC development and registration strategies as the RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams for assigned products throughout clinical development and commercial lifecycle with minimal supervision.  Develop and apply a comprehensive understanding of global RA CMC regulations and guidelines to projects to enhance probability of regulatory success and regulatory compliance.  Manage interactions with international Health Authorities,   successfully negotiating RA CMC matters, directly and indirectly. Develop constructive relations with key internal and external colleagues, including Alliance Partners.

                                                                                               

    • Plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities with minimal supervision.
    • As a project team leader or member, ensures and/or enhances regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life cycle.
    • Independently Defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements.
    • Represents RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters.
    • Interacts directly with international Health Authorities, as required.
    • Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner.
    • Evaluates change proposals for regulatory impact and filing requirements,
    • Fosters constructive working relationships when interacting with internal and/or external colleagues

    Qualifications

     

     

    What do you need to have?

     

    Education:  BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.

    Skills:

    • 6 + years pharmaceutical Regulatory CMC experience.
    • Alternatively, 4 + years pharmaceutical Regulatory CMC experience combined with 2+ years relevant pharmaceutical experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance) desired.
    • Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and product development meetings.
    • Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams
    • Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
    • Demonstrates leadership, problem-solving ability, flexibility and teamwork
    • Exercises good judgment in elevating and communicating actual or potential issues to line management.
    • Excellent written and oral communication skills required
    • Active participation in Agency/Industry groups/forums preferred

     

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

     

    • 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.

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