Dohmen Life Science Services

  • Regulatory Affairs Associate I/II

    Job Locations US-CO-Wheat Ridge
    Job ID
    2018-2000
    # of Openings
    1
    Category
    Consulting
  • Overview

    OUR COMPANY:

     

    Since 1858, Dohmen has been driven by the desire to get safe and effective treatments and cures to the people that need them most.  As entrepreneurs, we’ve looked for new and better ways of doing this year after year. Today, as Dohmen Life Science Services, we bring the industry’s most comprehensive service array to Medical Device, Biotech and Pharmaceutical entrepreneurs, helping them get farther faster and keeping them focused on innovations that improve lives. 

     

    Our behavior is guided by five simple values –

    Caring: We are empathetic and respectful.  We ask “how can I help you”

    Committed: We are dedicated and persistent.  We ask “how can I make it happen”

    Creative: We are inventive and imaginative. We ask “how can I do it better”

    Collaborative: We are cooperative and share our knowledge. We ask “how can we achieve success” 

    Courageous: We’re willing to risk failure over inaction. We ask “how can I challenge myself”

    This perspective defines us. How we act, how we do business, how we work with our clients and how we work with each other. They are essence of what makes us successful. They are what set us apart. 

     

     

     

    THE POSITION:

    The most important aspect of the position of the Regulatory Affairs Associate I or II is being responsible for managing the more complex regulatory aspects of projects, including the preparation and submission of correspondence and applications to regulatory agencies worldwide, with an emphasis on FDA premarket submissions.

     

    POSITION SUCCESS FACTORS:

    • Timeliness of managing multiple priorities and deliverables
    • Ability to manage multiple deliverables simultaneously
    • Working familiarity with eCTD structure

     

     

     

    Responsibilities

     

    Responsibilites:

    • Managing the regulatory aspects of projects, including applications submitted to various regulatory agencies.
    • Ensuring that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements.
    • Tracking the status of submissions as they progress through the regulatory review process.
    • Implementing strategic regulatory approaches for projects, as appropriate with oversight from the Regulatory Affairs or Regulatory Project Management Leads.
    • Assisting the Regulatory Affairs or Regulatory Project Management Leads with other duties.

     

     

     

     

    Qualifications

    MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

      • Bachelor’s degree in a scientific discipline
      • A minimum of 1-2 years of FDA regulatory experience is required preferably in the pharmaceutical/biologics/medical device industry
      • Ability to operate in a highly structured environment and manage multiple projects simultaneously
      • Excellent technical writing skills required
      • Excellent communication skills
      • Exposure to regulatory agencies, such as FDA and/or Notified Bodies is preferred
      • Ability to understand and explain detailed regulatory affairs and compliance programs and/or issues
      • Ability to comply with constantly changing regulatory procedures and prioritize work effectively
      • Strong Project Management capabilities
      • Experience with MS Office, Adobe Acrobat, and electronic submission software is a plus

       

      Personal skills/attributes/qualifications:

      • Attention to detail
      • Organizational skills
      • Timeliness of deliverables under tight timelines
      • Self-starter
      • Team-player
      • Able to work with direction that is not always specific, but asks for assistance if direction is not understandable
      • Able to explain reasoning that led to conclusions both orally and in writing

       

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