Senior Regulatory Affairs Associate

Job Purpose

Senior Regulatory Affairs Associate is responsible for handling the regulatory affairs for both internal investigator initiated studies and sponsored studies. The duties will include communications (and submissions to as appropriate) with CAGT investigators, IRB, other internal agencies. This position will also be responsible for the preparing of submissions to the FDA including new investigator initiated IND studies, as well as study amendments, safety reports and annual IND reports.

Job Duties

• Apply a detailed understanding of federal and international regulatory requirements when preparing regulatory review applications.
• Assist and advise Investigators on their compliance with federal and international regulatory requirements, obligations and responsibilities that govern the conduct of clinical research studies.
• Conduct regulatory affairs training.
• Support study monitoring, as needed.
• Communicate with IRBs and PIs related to submissions, renewals, and adverse events.
• Develop, implement, and maintain appropriate policies, procedures, and standards concerning projects.
• Serve as main contact for investigators, sponsors, government agencies, and the IRB.

Minimum Qualifications

• Bachelor's degree.
• Four years of relevant experience.

Preferred Qualifications

Certified Clinical Research Professional.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

5414

CA; CH