Intern, Regulatory Affairs-Canada
Innovaderm Research Inc. · Montréal, Quebec, CA
Description The Intern, Regulatory Affairs will support the Regulatory Affairs team in the preparation, organization, and maintenance of regulatory documenta...
Job description
Description The Intern, Regulatory Affairs will support the Regulatory Affairs team in the preparation, organization, and maintenance of regulatory documentation for clinical research studies. - Support the maintenance of regulatory files, trackers, and document repositories in accordance with internal procedures and regulatory requirements. - Contribute to the continuous improvement of regulatory processes and templates - Perform literature searches or regulatory research as assigned - Participate in the development of the regulatory intelligence database. - Assist with uploading regulatory documents in the Sponsor electronic Trial Master File (TMF) - Support the preparation of standard regulatory documents using existing templates. May participate in the development of Informed Consent Forms and regulatory/ethics submission documentation. - Participate in other regulatory or administrative tasks as assigned by the Regulatory Affairs team Requirements: Qualifications: - Undergraduate student in Life or Biological Sciences - Basic understanding of clinical trial research - Fluency in English with professional oral and written skills, required. Additional languages represent an asse...