EVERSANA

  • VP Regulatory Affairs (Remote)

    Job Locations US-CA-Emeryville
    Job ID
    2019-4472
    # of Openings
    1
    Category
    Compliance Services
  • Overview

     

    OUR CULTURAL BELIEFS

    Patient Minded I act with the patient’s best interest in mind.

    Client Delight I own every client experience and its impact on results.

    Take Action I am empowered and empower others to act now.

    Grow Talent I own my development and invest in the development of others. 

    Win Together I passionately connect with anyone, anywhere, anytime to achieve results.

    Communication Matters I speak up to create transparent, thoughtful and timely dialogue.

    Own It I hold myself and others accountable for results.

    THE POSITION:

    The most important aspect of the Regulatory Affairs Consulting Vice President is to be responsible for the Regulatory Affairs Consulting Service line (Pharmaceutical, Biologics, and Medical Devices). This position is a 50% billable, 40% business development and 10% leadership role. The Regulatory Affairs Consulting VP will be a Consulting Service Line Leader and ensure high quality consulting is provided to EVERSANA’s clients specifically as it relates to regulatory affairs. The most important aspect of the position of the Regulatory Affairs Consulting VP will be having the responsibility for managing the regulatory aspects of projects, including the preparation and submission of correspondence and applications to regulatory agencies. This person will function as a direct contact with regulatory authorities to facilitate the prompt review and approval of submissions. This position is a member of EVERSANA’s Executive Management Team (EMT). This position is also a member of the Management Review Team.

     

     

    Responsibilities

    ESSENTIAL DUTIES AND RESPONSIBILITIES:
    Our employees are tasked with delivering excellent business results through the efforts of their teams.  These results are achieved by:

    • This leader will spend 50% of their time providing high level strategic quality consulting (billable) and 40% of their time conducting business development activities and 10% of their time managing the regulatory affairs consulting organization which includes employees and 1099 contract employees
    • Managing the regulatory aspects of projects, including complex applications submitted to various regulatory agencies
    • Development of new customer projects that generate additional Regulatory 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
    • Participate in Regulatory speaking engagements as a way to actively rebrand EVERSANA and encourage additional market recognition
    • In conjunction with the Operations SVP, the incumbent will set the EVERSANA Regulatory strategy and support the group to execute against the strategy
    • 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
    • All other duties as assigned

    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

    PEOPLE LEADER

    People leaders must possess both the skills to effectively accomplish these tasks and the emotional intelligence to do so in alignment with our cultural values.  In addition to the critical management and leadership tasks listed above, this role also includes the following unique responsibilities:

     

    • Determine job objectives, work methods and performance standards; review performance relative to departmental objectives discussion appraisal with each employee and performance; authorize and communicate salary changes, promotions, transfers, discipline and discharge and administer all other personnel actions
    • Responsible for and oversee their respective department
    • Interview, select and supervise the activities of the department staff; communicate interpret and discuss with team the company policies and procedures
    • Ensuring that the training plans for his/her employees are developed and executed

    EXPECTATIONS OF THE JOB:

    • Responsible to deliver business results and new business for the regulatory affairs consulting group
    • Responsible to guide and mentor staff
    • Responsible to identify training and resource gaps to the appropriate EVERSANA management
    • Travel – Up to 25% required (may occasionally exceed 50%)
    • Hours – Average 50 hours/week

    The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.

     

    An individual in this position must be able to successfully perform the expectations listed above.

    Qualifications

    MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

    The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

     

    • Bachelor’s degree in a related discipline with a minimum of 15 years regulatory affairs experience is preferred; 10 years of regulatory affairs experience is required in the medical device industry; pharmaceutical experience highly preferred
    • A minimum of 10 years of FDA regulatory and quality systems experience is required
    • Incumbent must be able to operate in a highly structured environment and manage multiple projects simultaneously
    • Ability to work with and lead internal consulting employees within the regulatory affairs organization and external clients simultaneously
    • Ability to bring on additional quality consulting resources to fulfill EVERSANA consulting business commitments
    • Ability to manage multiple projects and deliverables in a timely fashion
    • Ability to bring in new business, execute signed quality statements of work with high degree of service, and provide upsell opportunities to existing clients
    • Internal and external customer focus
    • Timeliness in achieving deliverables
    • Organizational skills
    • Excellent written and verbal communication

     

    PREFERRED QUALIFICATIONS:

    • Experience managing technical resources is highly desired

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