Regulatory Officer

Company DescriptionWe 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 DescriptionJoin 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 applicationsCommunicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related mattersReview translations of essential documents subject to clinical trial submission.Track the regulatory project documentation flowReview documents to greenlight IP release to sitesManage safety reporting to authoritiesDeliver regulatory training to project teamsAssist with feasibility research and business development requestsQualificationsCollege/University degree or an equivalent combination of education, training and experiencePrior 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 applicationsDetail-orientedAbility to learn, plan and work in a dynamic team environmentCommunication, collaboration, and problem-solving skills Compensation: CAD 70000 - CAD 90000 - yearly

Prepare and manage clinical trial submission dossiers for Regulatory and Ethics Authorities, specifically for the US and Canadian markets. Coordinate with authorities, project teams, and vendors while managing safety reporting and regulatory training.

Requires a college or university degree and prior experience with North American clinical trial submissions. Full professional proficiency in English and French is required, with Spanish being beneficial.

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Clinical Trial Submissions
• Regulatory Affairs
• Ethics Submissions
• Import and Export Licensing
• Document Review
• Safety Reporting
• Project Tracking
• MS Office
• English Proficiency
• French Proficiency
• Spanish Proficiency
• Problem-solving
• Collaboration
• Communication
• Detail-oriented
• Planning

• Healthcare
• Science & Research
• Legal
• Administrative

Formation minimale

Baccalauréat

Expérience minimale

2+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine