Title:  Senior Regulatory Affairs Associate

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