The global CRO where clinical trials run on time.
Regulatory Officer
Location
Canada
Posted
19 days ago
Salary
$70K - $90K / year
Seniority
Senior
Job Description
Regulatory Officer
PSI CRO AG
• Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, with a specific focus on Canadian and US regulatory submissions, including Import and Export license applications • Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters • Review translations of essential documents subject to clinical trial submission • Track the regulatory project documentation flow • Review documents to greenlight IP release to sites • Manage safety reporting to authorities • Deliver regulatory training to project teams • Assist with feasibility research and business development requests
Job Requirements
- College/University degree or an equivalent combination of education, training and experience
- Prior experience with clinical trial submissions in North America
- Full working proficiency in English and French, native French speaker competency required, US Spanish speaker competency beneficial
- Proficiency in MS Office applications
- Detail-oriented
- Ability to learn, plan and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
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