Dohmen Life Science Services

  • Director, Regulatory Affairs Consulting (Home or Office Based)

    Job Locations US-CO-Wheat Ridge
    Job ID
    2018-2114
    # of Openings
    1
    Category
    Consulting
  • Overview

    OUR CULTURE:

    At Dohmen Life Science Services, we are committed to keeping our clients for life, ensuring no conflict of interest exists, achieving continuous innovation, and focusing on continuous improvement.  Our behavior is guided by five simple values that define how we work and are the essence of what makes us successful:

     

    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?”

     

     

    THE POSITIONVIRTUALLY BASED

     

    The Director of Regulatory Affairs will have the responsibility for managing the regulatory compliance service line and aspects of projects, including the preparation and submission of correspondence and applications to regulatory agencies. This position is a billable position and will be a member of DLSS’ Executive Management Team (EMT) as well as a member of the Management Review Team.

     

    This role will be responsible for global development strategies and the individual will be able to choose where the position will be based. 25-30% travel to clients as needed.

     

    POSITION SUCCESS FACTORS:

    • Ability to set a regulatory compliance consulting strategy
    • Ability to act as senior regulatory affairs consultant
    • Ability to work with internal employees and external clients simultaneously
    • Ability to manage multiple projects and deliverables in a timely fashion

    Responsibilities

    ESSENTIAL FUNCTIONS:

    • Managing the regulatory compliance service line which will involve a large use of 1099 resources. ALSO work as a Senior Regulatory Consultant managing the regulatory aspects of projects, including complex applications submitted to various regulatory agencies.
    • Development of new customer projects that generate additional Regulatory and Regulatory Compliance work as well as developing existing customer relationships leading to additional revenue, profit and referrals
    • Ensuring that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements.
    • Developing strategic regulatory approaches for projects, as appropriate with very limited oversight.
    • Preparing and writing complex submissions and other regulatory filings as required.
    • Planning and conducting formal meetings and teleconferences with regulatory authorities.

     RESPONSIBILITIES:

    • Manage and staff the Regulatory Compliance function and developing annual regulatory goals and objectives in conjunction with the DLSS EMT
    • Work as Regulatory Affairs Consultant in the regulatory strategy and projects group
    • Managing, training and mentoring regulatory associates and/or quality specialists

    Qualifications

    MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

    • Bachelor’s degree in a related discipline with a minimum of 8 years regulatory affairs experience is preferred; 10 years of regulatory affairs experience is required in the pharmaceutical industry; biologics experience a plus.

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