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Regulatory Affairs Associate PRC Coordinator (PT)

Company: Actalent
Location: Wake Forest
Posted on: August 6, 2022

Job Description:

This global bio pharma focused in oncology, neuroscience, and rare disease is looking to bring on a fully remote Regulatory Affairs Associate / PRC Coordinator (PT)!Job Description: This position will report to the Manager/Director of Commercial Regulatory Affairs and will manage regulatory activities within a highly regulated, and fast-paced industry to ensure that Company objectives are achieved in compliance with regulatory requirements. This position will specifically manage the review and approval of advertising and promotional materials by the Promotional Review Committee (PRC) and related activities in addition to other product regulatory activities, such as assisting in the submission of required FDA documents.--- Ensure successful implementation and maintenance of an efficient and compliant Promotional Review process--- Plan, prepare and attend PRC meetings and record accurate minutes--- Review promotional review submissions for completeness and compliance with established requirements--- Coordinate cross-functional reviews by PRC review team members.--- Track status of promotional materials and maintain archivesSkills:

  • Regulatory Affairs
  • Promotional Review
  • PRC
  • 2253
  • Veeva vaultAdditional Skills & Qualifications:--- Bachelor s degree required--- At least three years of experience in copy review or similar discipline --- Prior experience in the advertising and promotional environment 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, Raleigh , Regulatory Affairs Associate PRC Coordinator (PT), Other , Wake Forest, North Carolina

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