Manager, Regulatory Affairs
Manages and oversees regulatory affairs processes and procedures.
- Oversees compliance with international, federal, state, and BCM regulations governing clinical research in cell and gene therapy research.
- Assists and advises investigators on their compliance with above regulations and standards concerning projects conducted in the Center for Cell and Gene Therapy.
- Has primary responsibility for training, mentoring and supervising regulatory staff assigned to assist investigators in submission of cell and gene therapy clinical research projects. Such supervision includes confirmation of the work product.
- Develops, implements and maintains appropriate policies, procedures and standards to ensure that projects are completed accurately, legally, and in compliance with all regulations..
- Serves as the lead contact for investigators, sponsors, government agencies and the IRB for all clinical research conducted in the Center for Cell and Gene Therapy.
- Responsible for ensuring that all submissions and communications with regulatory agencies and sponsors are accurate and represent the goals of the clinical research project.
- Performs other job-related duties as assigned.
- Education Required: Bachelor's degree.
- Experience Required: Four years of relevant experience. Degrees in lieu of experience will not be accepted.
- Certification/Licenses/Registration: None Required.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.