Senior Regulatory Affairs Associate

Job Purpose

Senior Regulatory Affairs Associate is responsible for coordinating the regulatory and administrative requirements for conducting research; provides guidance in 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

• Education Required: Bachelor's degree.
• Experience Required: Four years of relevant experience.
• Certification/Licenses/Registration: None Required.

Preferred Qualifications

• Regulatory knowledge and communication skills to help prepare a new IND submission to the FDA.

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

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