1/31/14 – Regulatory Affairs Associate

Accentuate Staffing is currently recruiting a Regulatory Affairs Associate for a client of ours in RTP, NC.

Responsibilities

  • Facilitate interactions with co-workers and conduct problem-solving meetings to address critical and emerging work issues
  • Support the Chief Medical Officer with drafting templates, facilitating completion, and coordinating review of regulatory documents and submissions with internal/external authors and reviewers
  • Format and submit regulatory documents by required due dates and in accordance with applicable regulations
  • Support the preparation and submission of IND safety updates and additional information requested by regulatory agencies
  • Maintain paper and electronic regulatory master files, to include: regulatory index histories

Requirements

  • Associate’s or Bachelor’s Degree in a Scientific field
  • 2-5 years of experience in Regulatory Affairs, to include: early stage pharmaceutical development
  • Regulatory Affairs Certification (RAC) is a plus
  • Experience organizing and maintaining regulatory files; eCTD experience is preferred
  • Experience in an ex-US regulatory environment is a plus
  • Experience developing topical formulations is a plus