Regulatory Affairs Associate - III

Apex Life Sciences Foster City, CA

Description:

  • Responsible for maintaining the Endnote Repository Library by adding new references, searching for citations, and modifying references if necessary.
  • Also adding reference articles, abstracts, presentations to the Regulatory Document Management System (RDMS).
  • Should possess some knowledge of a document management system.
  • Other responsibilities include electronic quality control (eQC).
  • This entails verifying Acrobat PDFs are submission ready by validating hyperlinks, bookmarks, document properties, and overall look of the document.
  • General knowledge of Adobe Acrobat is preferred.
  • Participate in group meetings and present updates on Endnote and eQC.
  • Responsible for developing and acquisition of regulatory skills and knowledge.
  • May contribute to process improvements which may have significant impact on the group and other functional areas.
  • Excellent organization skills are required.
  • Excellent verbal and written communications skills and interpersonal skills are required.
  • Work is performed under supervision of the Document Processing manager.