Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Position Overview
In The Research department is critical to this mission because we offer patients access to novel therapies and opportunities that are unavailable outside of a clinical trial. We ensure that our trial opportunities support the cancer needs of our community and continue to grow our team with high skilled, compassionate research team members in our premier research program.
The Research Coordinator and Regulatory Associate is key to the Research team in supporting for our clinical trial patients by screening for eligible patients to enroll in clinical trials, coordinating research activities per protocol and as delegated by the Research Nurse(s) and Director of Research. In addition, a important function of this role is to support compliance with the regulatory requirements to meet local and federal guidelines, regulations, and laws and engaging the Research team and the Principal Investigator in meeting rigorous standards. Approximately half of the time will be spent as a Research Coordinator and the other half spent as a Regulatory Associate.
Essential Job Functions
Required Qualifications
Preferred Qualifications
Would you thrive in this position?
0 Regulatory Affairs Specialist jobs found in Salem, OR area