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Senior Regulatory Affairs Specialist

Company: Kelly
Location: Cherry Hill
Posted on: February 20, 2021

Job Description:

Senior Regulatory Affairs Specialist
Cherry Hill, NJ

Direct Hire/Salaried



Position Overview: The Senior Regulatory Specialist is responsible for preparing regulatory and technical documentation to support and obtain regulatory approvals and maintain regulatory compliance.


Responsibilities:


  • Prepare regulatory and technical documentation—compositions, SDSs, company statements—or review same prepared by associates to ensure accuracy, completeness and appropriateness for internal and external (customer) distribution
  • Manage FDA registration of necessary products, including Medical Devices and OTC Drugs
  • Manage or support ad hoc projects to streamline regulatory processes and support R & D and production units or meet other business needs
  • Advise both internal and external parties on technical matters and regulatory requirements and provide guidance on meeting those requirements
  • Communicate technical information related to our product portfolio to our customer base to address inquiries
  • Perform periodic quality reviews of shipments and batch records
  • Some quality assurance responsibilities, e.g. internal audits, may be assigned



    Qualifications


    • B.S./B.A. degree required with a strong preference for a chemistry or engineering related major
    • Minimum 5 years' regulatory experience in an FDA regulated environment
    • cGMP and ISO 13485 experience
    • Ability to read, understand, interpret, and apply technical literature, regulations, and regulatory guidance
    • Above-average Excel knowledge and ability to learn and apply new computer software programs
    • Highly organized
    • Ability to prioritize and track multiple concurrent projects
    • Ability to communicate effectively, especially through written media



      Desired Skills


      • Experience in the cosmetics industry
      • Technical role in an FDA-regulated environment is beneficial
      • Prior experience in support or development of a certified quality system, e.g. ISO, is also preferred
      • Regulatory affairs certification (RAC) or coursework is advantageous.
      • SHE, OSHA, EPA, DEP, air permits

        Why 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, Cherry Hill , Senior Regulatory Affairs Specialist, Other , Cherry Hill, New Jersey

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