Regulatory Affairs Specialist
16 hours ago
Description
• 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.
Requirements
• Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs. • The successful candidate will possess strong knowledge of EMA regulations.
Benefits
• Accommodations for job applicants with disabilities are available upon request.
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