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Regulatory Affairs Specialist
| Company | Alimentiv |
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| Location | Toronto, ON, Canada |
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| Salary | $76000 – $127000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Mid Level, Senior |
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Requirements
- Minimum of an undergraduate degree
- 4-6 years of relevant experience in Clinical Research/Regulatory Affairs
- Strong knowledge of EMA regulations
Responsibilities
- Manage clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies
- Develop stakeholder tools and process/document regulatory risk assessments
- Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines
- Coordinate the day to day delivery of regulatory services and processes
- Conduct or assist with regulatory and/or safety reviews
- Provide regulatory, ethics and/or pharmacovigilance guidance and support to project stakeholders
- Identify changes in clinical research regulatory requirements and industry best practices
- Regularly respond to registration requests and work with project teams to identify regulatory requirements
- Assist in the preparation of regulatory submissions and support summaries
Preferred Qualifications
No preferred qualifications provided.
