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Randstad US VP, Regulatory Affairs in Morristown, New Jersey

VP, Regulatory Affairs

job details:

  • location:Morristown, NJ

  • salary:$225,000 - $250,000 per year

  • date posted:Tuesday, November 9, 2021

  • experience:15 Years

  • job type:Permanent

  • industry:Professional, Scientific, and Technical Services

  • reference:39096

job description

VP, Regulatory Affairs

job summary:

*URGENT NEED for a VP, Regulatory Affairs to manage FDA Advisory Committee Programs: Play a senior management role in projects involving FDA Advisory Committee management, including, leading team meetings.*

location: Morristown, New Jersey

job type: Permanent

salary: $225,000 - 250,000 per year

work hours: 9 to 5

education: Doctorate

responsibilities:

  • Manage FDA Advisory Committee Programs: Play a senior management role in projects involving FDA Advisory Committee management, including, leading team meetings, managing project timelines, developing slide decks, and drafting briefing books.

  • Manage Regulatory Projects: Play a senior role in provide guidance to clients relating to drug and medical device safety and efficacy evaluations and activities related to FDA product approvals.

  • Scientific Summary and Analysis: Review scientific studies and data relevant to a particular scientific issue and provide meaningful written and/or oral critical analysis and integration as to how it affects the client objectives.

  • Client Interaction: Provide oral and written communication with clients to convey project status, interim reports, and final project deliverables.

  • Program Management: Supervise client projects and ensure that they are completed with high degree of accuracy and quality and that they are within budget and on time.

qualifications:

  • Advanced degree (preferred in a life science or related field) 15+ years' experience

  • Relevant work experience; preferably in regulatory affairs and/or project management; previous experience with regulatory submissions, regulatory body meetings (e.g. FDA Advisory Committees) a plus

  • Proficient and comfortable with scientific/medical data and nomenclature

  • Ability to effectively communicate complex scientific and regulatory principles to non?scientists (as well as to scientists and healthcare professionals)

  • Proficient with Word, Outlook, Excel, and PowerPoint

skills: Regulatory Affairs Operations, Regulatory Affairs Strategy

For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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