Regulatory Affairs Staffing for on-time, first-time acceptance
Regulatory Affairs staffing services can be used to identify specialists to:
- Keep your team on track to a timely regulatory submission (IND, NDA, BLA, PMA, IDE or similar regulatory submissions)
- Achieve a high-quality (defined as first time acceptance) submission
- Obtain regulatory 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 regulatory support for either domestic or international submissions
- Work toward ending a consent decree, regulatory hold or other roadblocks
Our expertise in regulatory affairs extends back over 25 years. Our CEO, Rosemarie Christopher was a member of the Regulatory Affairs Professional Society (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 Presidents of Regulatory Affairs down to entry level regulatory 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. We also insure each contract worker for errors, omissions and even fraud. We handle bi-weekly reporting and 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 insure they see their project through to the end.
Regulatory Affairs Staffing Positions
- Regulatory and Compliance Apprentices
- CMC Regulatory Manager
- Regulatory Affairs Specialists
- Document Control Associates
- Regulatory Associates
- Regulatory Affairs Managers
- Directors of Regulatory Affairs
- Regulatory Affairs Consultants
- Medical Writers
- Vice President of Regulatory Affairs
Talk to someone about Regulatory Affairs Staffing
Contact us today to schedule a time and discuss your company’s specific needs.