Psicro
Regulatory Officer
Mississauga, ON, Canada
Sponsorship not specifiedDetected 23 days ago
Business DevelopmentResearchCommunicationCollaborationProblem SolvingMicrosoft Office
About the 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
- Track the regulatory project documentation flow
Responsibilities
- Manage safety reporting to authorities
- Deliver regulatory training to project teams
Requirements
- 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
- Ability to learn, plan and work in a dynamic team environment
Skills
- Communication, collaboration, and problem-solving skills
Company info
- 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.
- 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.
This listing is sourced directly from Psicro's careers page and normalized into a canonical job model.