Regulatory Affairs Associate
The Research Resource Office is looking for an experienced Regulatory Affairs Associate to coordinate and assist with regulatory requirements and regulatory administrative support associated with clinical trials in the Department of Pediatrics. Will handle regulatory affairs for internal investigator initiated studies and sponsored studies. The Regulatory Affairs Associate is responsible for preparing submissions to the FDA including new investigator initiated IND studies, as well as study amendments, safety reports and annual IND reports. Other duties will include communications with investigators, IRB, other internal groups.
- Manage clinical study regulatory work for a research study or clinical trial in a compliant fashion, assuring they are audit-ready.
- Assist with IND/IDE submission and reporting to the FDA and other government agencies.
- Communicate with IRBs and PIs related to submissions, renewals, and adverse events.
- Responsible for regulatory submissions to FDA and foreign regulatory agencies. Assist in the preparation of correspondence, quarterly reports, or as needed, and other documentation.
- Serve as main contact for investigators, sponsors, government agencies, and the IRB. In doing so, build and maintain effective and professional relationships with key personnel and regulatory agencies.
- Track and analyze key outcomes measures, identify areas of opportunity, and communicate results clearly.
- Bachelor's degree.
- Two years of relevant experience.
- Must be able to manage multpile deadlines and other time sensitive activities.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.