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.
Applies a detailed understanding of federal and international regulatory requirements when preparing regulatory review applications.
Assists and advises Investigators on their compliance with federal and international regulatory requirements, obligations and responsibilities that govern the conduct of clinical research studies.
Conducts regulatory affairs training.
Supports study monitoring as needed.
Communicates with IRBs and PIs related to submissions, renewals, and adverse events.
Develops, implements, and maintains appropriate policies, procedures, and standards concerning projects.
Serves as main contact for investigators, sponsors, government agencies, and the IRB.
Performs other job-related duties as assigned.
Education Required: Bachelor's degree.
Experience Required: Four years of relevant experience.
Certified Clinical Research Professional is preferred.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
Baylor College of Medicine fosters diversity among its students, trainees, faculty and staff as a prerequisite to accomplishing our institutional mission, and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care.
- Diversity, respect, and inclusiveness create an environment that is conducive to academic excellence, and strengthens our institution by increasing talent, encouraging creativity, and ensuring a broader perspective.
- Diversity helps position Baylor to reduce disparities in health and healthcare access and to better address the needs of the community we serve.
- Baylor is committed to recruiting and retaining outstanding students, trainees, faculty and staff from diverse backgrounds by providing a welcoming, supportive learning environment for all members of the Baylor community.