PRAHS

  • Manager, Regulatory Strategy CMC

    Job Locations - | Germany
    Posted Date 2 months ago(4/9/2018 3:50 PM)
    ID
    2018-46275
  • 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 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 Manager, Regulatory Strategy CMC, you will develop and lead 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.  Develops comprehensive understanding of global RA CMC regulations and guidelines, and apply 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, with moderate supervision.  Interacts with other internal and external colleagues, as well as with other functional areas and Alliance Partners.

     

     

    • Plans, executes and manages regulatory submissions for assigned compounds with appropriate supervision from RA CMC Management.
    • Defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements, with appropriate oversight of RA CMC Management.
    • With moderate supervision, represents RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters 
    • Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
    • Evaluates change proposals for regulatory impact and filing requirements.

    Qualifications

     

    What do you need to have?

     

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

    Skills:

    • 4 + years pharmaceutical Regulatory CMC experience. Alternatively 3+ years pharmaceutical Regulatory CMC experience combined with 2+ years relevant pharmaceutical experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance) desired
    • Some experience participating in meetings with Regulatory Agencies preferred.
    • Ability to understand, apply, and articulate regulatory CMC requirements for global drug development and post-market support initiatives required.
    • Demonstrates leadership, problem-solving abilities, and exercises appropriate judgement when working with project teams
    • Exercises good judgement 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 preferredGood understanding of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
    • Solid teamwork, organizational, interpersonal, and problem solving skills; exercises good judgment with respect to confidential information and strategies
    • Fluent business English (oral and written) and basic medical writing skills
    • Experience: Minimum of 3 years of experience in clinical research in the pharmaceutical industry or clinical research organization.  CRA experience and protocol writing/study design experience 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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