Regulatory Affairs Manager

1. Understand the processes and purposes of clinical research regulatory submissions, reports and registrations.
2. Examples include IRB regulations, Good Clinical Practice, IND/IDE and other FDA regulations, and the Common Rule.
3. Develop and review documentation for accuracy and consistency with regulatory strategy to ensure completion of high-quality submissions compliant with FDA, TFDA and international regulations and guidelines within agreed upon timelines.
4. Research scientific and regulatory information in order to write, edit, and review documents for regulatory submissions.
5. Review protocols and clinical trial plans and ensure alignment with regulatory requirements, as assigned.
6. Collaborate with Regulatory Affairs staff and contributing functional areas to assure adequate prioritization, scheduling, preparation and dispatch of regulatory submissions.
7. Manage projects with third party vendors and contractors to meet schedules and ensure quality.
8. Assists with trial start up activities from initial protocol review and site selection through study activation.
9. Evaluate programs, policies and procedures. Identify issues, and develop alternative solutions which may include changes to programs, policies and procedures.
10. Develop meeting minutes for clinical trial project meetings (internal or external).
11. Perform other duties as assigned.