Senior Regulatory Affairs Associate
Baylor College of Medicine
Houston, TX
Job posting number: #7310410 (Ref:22734-en_US)
Posted: June 12, 2025
Job Description
Summary
Senior Regulatory Affairs Associate is responsible for coordinating the regulatory and administrative requirements for conducting research; provides guidancein the accumulation of regulatory documentation.
Job Duties
- 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.
Minimum Qualifications
- Bachelor's degree.
- Four years of relevant experience.
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.
