Regulatory Affairs Staffing for on-time, first-time FDA acceptance

Regulatory Affairs staffing services can be used to identify specialists to:

  • Keep your team on track to a timely submission (IND, NDA, BLA, PMA, IDE or similar submissions)
  • Achieve a high-quality (defined as first time acceptance) submission
  • Obtain FDA approval of product labeling
  • Navigate regulatory road maps, such as for orphan diseases, which will speed up the clinical trial cycle, the regulatory process and garner more government resources
  • Provide critical support for either domestic or international submissions
  • Work toward ending a consent decree, regulatory hold or other roadblocks


Our expertise in regulatory affairs staffing extends back over 25 years. Our CEO, Rosemarie Christopher was a member of RAPS for over 23 years. Lewie Casey is our lead recruiter for Regulatory and Quality positions. He has been with us for over ten years and is an active member of OCRA – Orange County Regulatory Affairs Discussion Group. Our team has placed Vice President of Regulatory Affairs down to entry level staff.  We also created the Regulatory and Compliance apprenticeship that is recognized and funded by the US Department of Labor and the State of California.

You Are Covered

We have processes to keep you out of trouble. We cover taxes and workers compensation and also insure each contract worker for errors, omissions and even fraud. Bi-weekly reporting is used to monitor their progress toward achieving your business goals.

Contract workers are paid bi-weekly. We offer each a full range of benefits including healthcare, vision, and dental. This helps ensure they see their project through to the end.

Regulatory Affairs Staffing Positions

  • Regulatory and Compliance Apprentices
  • CMC Manager
  • RA Specialists
  • Document Control Associates
  • Regulatory Associates
  • RA Managers
  • Directors of Regulatory Affairs
  • RA Consultants
  • Medical Writers

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