Regulatory affairs (RA) personnel help Colorado State University (CSU) ensure compliance with regulations and standards, particularly in the areas of healthcare-related discovery and product development.  Core responsibilities of CSU RA personnel include supporting approval of new products, managing compliance, identifying and mitigating risks, and serving as liaisons with regulatory agencies.

Examples of areas that CSU RA may be involved:

1. Aiding in the accurate presentation of scientific thinking and data
2. Counseling CSU researchers and personnel on scientific requirements and restrictions
3. Providing technical and strategic advice
4. Establishing processes, including policies and guidelines, for commercial and scientific success
5. Helping to maintain regional, state, national, and global compliance
6. Acting as a bridge between CSU, its researchers, and regulatory authorities
   • Creating regulatory submissions for health authorities such as the US Food and Drug Administration (FDA)
   • Communicating with regulatory agencies to stay current and negotiate plans
7. Tracking changing regulations and assessing their impact on CSU and its researchers
8. Identifying and mitigating regulatory risks

Questions? Please reach out to Tracy Webb || (970)297-4237