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
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 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.
PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry, originating in Switzerland as a privately owned, full-service firm. The company supports clinical trials across multiple countries and continents, managing comprehensive trial operations including investigator site identification, patient enrollment, monitoring, data integrity, and regulatory compliance. PSI is known for being highly selective about projects and delivering high-quality, timely services across a broad spectrum of therapeutic indications. The company also develops internal IT solutions with a focus on AI initiatives to support business processes and operations.
