Regulatory Affairs Officer
PSI CRO
- Toronto, ON
- Permanent
- Full-time
- Responsible for liaising with project teams to procure documents necessary for regulatory and ethics committee submissions.
- Responsible for the preparation of regulatory and ethics committee submission dossiers, including applications for import and export licenses, where applicable.
- Responsible for reviewing translations of essential documents subject to regulatory or ethics committee submissions, if regionally applicable (shared with project teams).
- 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).
- 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 release-enabling documents.
- Primary or secondary responsibility for training company employees in
- Must have a College/University degree or an equivalent combination of education, training and experience.
- Must have 3+ years of hands-on relevant Regulatory Affairs experience.
- Experience with the review, maintenance, and compilation of the US 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.
- Proficiency in MS Office applications.
- Detail-oriented, ability to learn, plan and work in a dynamic team environment.
- Must have excellent communication, collaboration, and problem-solving skills.