Regulatory Affairs Specialist I

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Develop and uphold a document management system for regulatory electronic files.

• Oversee FDA and GCP mandated regulatory documentation for individual sites, studies, sponsors, and/or other networks.

• Ensure that regulatory documentation adheres to local Standard Operating Procedures (SOPs) concerning format and content.

• Maintain essential documentation to guarantee compliance.

• Revise and/or create informed consent forms.

• Update and manage modifications or amendments to protocols, investigator drug brochures, and consent forms in accordance with IRB policy and HIPAA.

• Manage time-sensitive communications with sponsors and other stakeholders.

• Organize and process documentation for IRB submissions across multiple trials.

• Address protocol deviations that meet IRB reportable criteria.

• Submit urgent safety notifications to the IRB.

• Oversee and strategize regulatory affairs compliance for industry sponsors and/or sites within networks.

• Collaborate closely with regulatory affairs management, the department director, and/or primary investigators.

• Prepare for auditing activities while adhering to strict deadlines.

• Maintain a comprehensive study workload with minimal supervision.

• Execute additional duties as assigned.

⛳️ Requirements

• A high school diploma is required.

• An Associate's Degree or higher is preferred.

• Relevant experience may be accepted in lieu of educational qualifications.

• At least 1 year of experience in clinical research, pharmaceutical, or site management organizations, particularly in required regulatory affairs, is highly desired.

• Familiarity with medical terminology is highly preferred.

• Understanding of FDA and other regulatory processes is highly preferred.

• Capability to maintain a full study workload with minimal supervision.

• Sponsorship is not available.

🏝️ Benefits

• A comprehensive Total Rewards package that supports physical, mental, and financial well-being.

• Competitive compensation package.

• Opportunities for an annual bonus or long-term incentives may be provided.

• Access to resources and opportunities for personal growth and development.

• Fully remote work arrangement.