Regulatory Affairs and Quality Specialist

7 days ago

Toronto, Ontario, Canada Ozmosis Research Inc. Full time
JOB SUMMARY

The Quality Assurance & Regulatory Affairs Specialist (QARAS) supports the Senior Director of Quality Assurance & Regulatory Affairs (SDQARA) and the Ozmosis team in quality control/quality assurance and regulatory affairs.


QUALIFICATIONS
  • Completion of a Bachelor's of Science degree or recognized equivalent
  • Experience in Oncology, Clinical Trials, Good Clinical Practice, Quality Control/Assurance, Regulatory Affairs involving human subjects, preferred
  • Experience in CTA including Preparation of Module 2, IND, ITA submissions preferred
  • Good written and verbal communication skills, excellent organization, prioritization skills, excellent computer skills and the ability to learn quickly
  • Ability to work under pressure and attention to detail
  • Ability to perform duties professionally, produce high-quality work, and meet deadlines following Ozmosis Research Inc. standards
  • Good critical thinking skills with the ability to multi-task
  • Ability to work well as part of a team
  • Knowledge of Health Canada and FDA regulations relating to Clinical Trials

KEY ACCOUNTABILITIES & RESPONSIBILITIES
  • Prepare and submit regulatory submissions to Health Canada and FDA
  • Liaise with regulatory authorities and internally to ensure timely response to requests
  • Assist with preparation for regulatory meetings
  • Perform quality control reviews and audits, communicate results, and oversee resolution
  • Support the development and maintenance of tools, trackers, and documents related to Regulatory Affairs, QC/QA
  • Manage the maintenance of various logs, documents, and eTMF index
  • Responsible for SOP revisions, approvals, training documents, and Document Control
  • Provide assistance with metrics analysis, internal audits, and audit reports
  • Contribute to Ozmosis SOPs, documents, and guidelines
  • Other responsibilities may be required depending on business needs

Ozmosis Research Inc. offers benefits, a pension plan, and a competitive salary based on experience and skills. We appreciate all applicants' interest, and only selected candidates will be contacted. Thank you.

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