Senior Regulatory Specialist

Summary

Join our team as a Senior Regulatory Specialist at Care Access, where you will oversee regulatory details for assigned trials, ensure compliance, and support start-up activities.

Responsibilities

• Develop and execute regulatory strategies to obtain and maintain regulatory approvals for Care Access projects
• Lead communications and serve as main contact with regulatory bodies
• Develop, review, and submit high-quality and timely regulatory agency submission materials, including but not limited to protocols, ICFs and marketing materials
• Stay updated on evolving regulations, guidelines, and industry best practices to ensure compliance and adjust strategies
• Collaborate closely with cross functional teams, including, but not limited to senior leadership, patient marketing and study operations
• Track essential documents and timelines
• Handling submissions to the IRB, management of essential regulatory documents
• Maintain centralized document storage
• Ensure quality is maintained in all investigator site files for assigned studies
• Support sites through their evaluation and begin start-up activities upon selection
• Support the site through the Site Evaluation Visit, Site Initiation Visit, greenlight to consent, and Study Closeout
• Support audits and monitoring visits to ensure regulatory compliance
• Oversee activities throughout the duration of the study; supporting clinical operations teams as required
• Review study information and understand start-up timelines, requirements, key contacts, and performance expectations
• Actively work towards KPIs to help ensure departmental success
• Liaise with key stakeholders across the global organization to communicate needs and establish start-up timelines
• Work with department head on new initiatives and projects to help grow department
• Display high level of integrity and professionalism
• Perform other duties as assigned