Pediatric Clinical Regulatory Affairs Associate (Onsite)

Baylor College of Medicine; Houston (TX); On-site; USD 71,000 - 83,000; Full time

Job summary

Baylor College of Medicine is seeking a Regulatory Affairs Associate for the Clinical Research team in the Department of Pediatrics at TXCH. The role focuses on regulatory compliance for a portfolio of clinical trials, including protocol review, submissions, and adherence to ICH GCP guidelines.

Ideal candidates will have CCRP/CCRC certification eligibility and strong working knowledge of federal regulations, with the ability to navigate approvals and maintain up-to-date regulatory documentation

Qualifications

• Two years of relevant experience in regulatory affairs for clinical research.
• Knowledge of federal regulations, ICH GCP, and SOPs.
• Ability to manage regulatory submissions and communications with IRB/regulatory bodies.

Responsibilities

• Coordinate regulatory correspondence across internal stakeholders and external institutions.
• Prepare protocol documents and regulatory forms to obtain approvals for clinical research.
• Maintain regulatory databases and study files to ensure audit readiness.
• Assist with FDA meetings, inspections, and audits; respond to inquiries from regulatory authorities.

Skills

Regulatory affairs

Clinical research knowledge

Regulatory compliance

Education

Bachelor's degree

Job description

Baylor College of Medicine is seeking a Regulatory Affairs Associate for the Clinical Research team in the Department of Pediatrics at TXCH. The role focuses on regulatory compliance for a portfolio of clinical trials, including protocol review, submissions, and adherence to ICH GCP guidelines.

Ideal candidates will have CCRP/CCRC certification eligibility and strong working knowledge of federal regulations, with the ability to navigate approvals and maintain up-to-date regulatory documentation