Title:  Senior Regulatory Affairs Associate

Division:  Molecular Virology and Microbiology
Schedule:  Monday - Friday, 9:00 a.m. - 5:00 p.m.
Work Location:  Houston, TX
Salary Range:  $85,000 - $100,000
FLSA Status:  Exempt
Requisition ID:  14227

Summary

Senior Regulatory Affairs Associate is responsible for managing, supervision and training related to the regulatory function for clinical trials in the Vaccine Research Center.

Job Duties

  • Lead the effort in the department to transition from paper regulatory files to electronic system.
  • Supervise and train employees to manage regulatory files.
  • Prepare all initial, amendment and continuing review submissions for clinical trials, ensuring adherence with internal timelines and any external deadlines.
  • Manage multiple competing priorities of deadlines and projects while maintaining a high quality work produce in the context of opening clinic trials within the Vaccine Research Center.
  • Direct investigators to insure their compliance with regulatory requirements, obligations and responsibilities.
  • Create and maintain the site regulatory filing system (paper and electronic) according to established guidelines.
  • Manage regulatory documents for all research studies in a comprehensive manner.
  • Assist with quality assurance of research records including query resolution.
  • Work with research clinic personnel to ensure regulatory compliance.
  • Provide approved regulatory documents (including revisions) to research clinic personnel.
  • Facilitate regulatory record review by Clinical Research Associates representing clinical trial Sponsors.
  • Communicate with IRBs, PIs, quality management personnel, and clinic personnel regarding regulatory document submissions and approvals.
  • Track training requirement compliance and ensures renewal of necessary training in a timely manner (prior to expiration).
  • Attend internal educational meetings that apply to regulatory affairs or research unit operation.
  • Serve as the main contact for investigators, clinical staff, sponsors, government agencies, and the IRB.
  • Train all new clinic personnel to regulatory affairs.

Minimum Qualifications

  • Bachelor's degree.
  • Four years of relevant experience.

Preferred Qualifications

  • Must be a subject matter expert in the understanding of federal and international regulatory requirements (FDA, ICH/GCP, local affiliate rules)
  • Experience in clinical research trials
  • Certification as a Research Professional (SOCRA or ACRP certified)
  • Must be able to work independently and as part of a team unit and possess the interpersonal skills necessary to work productively with a variety of internal and external stakeholders
  • Proficient attention to detail

 

 

Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.

 

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

 14227

CA; CH