Regulatory Officer
Full-time
PSI CRO
We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 3,200 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.
Job Description
Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.
Your role:
- 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
Qualifications
- 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
Vacancy posted 21 days ago
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