Regulatory Officer
About the role
Company Description 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
Compensation: CAD 70000 - CAD 90000 - yearly
Not the right fit? Search for Regulatory Officer jobs in Mississauga, Ontario, Canada
About PSI CRO AG
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
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Regulatory Officer
About the role
Company Description 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
Compensation: CAD 70000 - CAD 90000 - yearly
Not the right fit? Search for Regulatory Officer jobs in Mississauga, Ontario, Canada
About PSI CRO AG
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.