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Regulatory Affairs Manager

Company: Kelly Services
Location: Princeton
Posted on: April 9, 2021

Job Description:

Every day, Kelly Scientific Resources connects scientific professionals with opportunities to advance their careers, and we currently have an opening for an Regulatory Affairs Manager near Princeton, NJ.Responsibilities:

  • Ensure timely submissions of documentation to Regulatory Authorities globally prior ot the performance of clinical trials, and again prior to marketing of new pharmaceutical products
  • Ensure that documents are prepared to the required standards related to drug submissions and clinical research
  • Provide regulatory consultancy advice to client companies and/or company project team
  • Will act as liaison between the client and Regulatory Authorities
  • Assist company staff in business development activities related to regulatory submissions--Requirements:
    • Must have 3+ years' experience with IND and publishing modules 1-5
    • Must know the entire regulatory process - US applications
    • Experience with CROs
    • Must be able to manage multiple projects and be flexible with changing projects
    • Leadership experience
    • 5 years' experience in Pharmaceutical industry in Regulatory Affairs or Drug Development
    • Excellent communication, organization and planning skills with attention to detail--Position is due to growthNo direct reports to start out, but the team is growingContract to hire positionMust be local to commute to the Princeton, NJ area.-- Due to COVID the position is remote at this time, but if/when things change in the future, must be able to come into office.Pay: $100/hrWhy Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, Trenton , Regulatory Affairs Manager, Executive , Princeton, New Jersey

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