other
Posted 3 hours agoRegulatory Affairs Specialist (North America, LATAM, EU)
at Alimentiv
Toronto, CanadaOn-site
Responsibilities
- 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.
Requirements
- May be required to coach peers and/or provide input for staff performance reviews.
Additional details
- 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.