Regulatory Affairs Specialist (North America)

Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. Develop stakeholder tools, process/document regulatory risk assessments, and provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities.  Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines.  May be required to coach peers and/or provide input for staff performance reviews.