Regulatory Affairs Officer - Toronto, Canada - PSI CRO
Description
Company Description
PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.
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:
- Responsible for liaising with project teams to procure documents necessary for regulatory and ethics committee submissions.
- Primary responsibility for tracking regulatory project documentation flow and progress reporting.
- Supervised responsibility for maintaining a database of regulatory requirements.
- Primary or secondary responsibility for registration/marketing authorization projects and renewals (where applicable).
- Primary or secondary contact person for ethics committees and regulatory authorities, project teams on all regulatoryrelated issues, and cocontractors, subcontractors, and third
- Secondary responsibility for the development and update, if necessary, of project planning documents, including project timelines (regulatory aspects) and safety management plan, where applicable (in cooperation with Medical Affairs).
- Responsible for review of investigational product releaseenabling documents.
- Primary or secondary responsibility for training company employees in
- Responsible for ensuring accurate and timebound reporting of
- Provide assistance to business development at client presentations, bid defense meetings, and the like in various regulatory aspects (at the discretion of Senior Regulatory Affairs staff).
Qualifications:
- Must have a College/University degree or an equivalent combination of education, training and experience.
- Must have 3+ years of handson relevant Regulatory Affairs experience.
- Experience with the review, maintenance, and compilation of the IND lifecycle and submissions.
- Experience interacting with and acting as the liaison with the FDA/Sponsor/ etc.
- Prior experience with Health Canada is a plus.
- Detailoriented, ability to learn, plan and work in a dynamic team environment.
- Must have excellent communication, collaboration, and problemsolving skills.
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
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