In order to efficiently handle regulatory requirements, you need to establish an operating model that connects end-to-end processes across the drug development team. Regulatory Operations is the key to creating this model.
- Regulatory Communications (written & oral)
- Meeting requests
- Project Manager interface
- U.S. FDA agent representation
- Identification of all pertinent procedures, guidances, regulations, and laws
- Coordinate resources and documentation essential for filing of regulatory applications such as INDs, NDAs, BLAs and MAAs for pharma/biotech organizations and of 510k and PMAs for medical device organizations
- Organization and participation in FDA meetings (meeting minutes, follow-up correspondence)
- Review, support and coordination of annual reports, clinical study reports, ClinicalTrials.gov compliance, etc.