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Regulatory Specialist

Company: Actalent
Location: Princeton
Posted on: September 21, 2022

Job Description:

This opportunity is with one of the TOP Academic Research sites in the greater Philadelphia area, who are looking for a Regulatory Coordinator to join their Cancer Center. This company has great culture and offers strong career advancement! Description:

  • Process all initial regulatory documents for submission to the Pharmaceutical Sponsors and Institutional Review Board (IRB)
  • Prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees
  • Prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA.Additional Skills & Qualifications:
    • MUST HAVE Experience submitting to the IRB a minimum of 10 times
    • A Bachelor's Degree and 2-5 years of experience (or equivalent combination of education and experience is required)
    • 3+ years relevant experience in an academic regulatory environment
    • IND/IDE/Clinical Trial Application experience
    • Knowledge and experience with FDA Clinical Trial regulations and guidelines
    • Demonstrated ability to work on projects with some independence
    • Strong writing skills
    • Review and edit policies
    • Ability to work in a team environment and independently Experience Level:Intermediate Level About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Trenton , Regulatory Specialist, Other , Princeton, New Jersey

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