Assistant, Regulatory Affairs and Product Safety

March 9 2020
Categories Pharma, Biotech, Sciences, R&D, Scientific and Regulatory affairs, Pharmacovigilance
Montreal, QC

Job Summary

Working within Regulatory Affairs, reporting to the Regulatory Affairs Specialist, the Assistant, Regulatory Affairs and Product Safety is responsible for performing all of the required Regulatory Affairs, Pharmacovigilance (PV) and the required Complaints/Adverse reactions/Queries (CAQ) activities.

Principal Responsibilities

Regulatory Affairs:

  • Assist in compiling, maintaining and submitting product (DIN, NPN, other) applications as well as manufacturing license (DEL, SL, other) and maintenance thereof (e.g. Post-DIN Changes, Supplements, Annual Notifications, Amendments, Notifications) with Health Canada or other Health Authorities; assist in responding to any deficiencies or questions from Health Authorities.
  • Keep abreast of any changes to Guidelines, Regulations, coordinate communication, training and implementation thereof.
  • Perform other relevant duties, as required.

Pharmacovigilance (PV), in collaboration with third party vendor, as needed:

  • Perform literature search and screening on a defined, regular basis.
  • Review Annual Summary Reports.
  • Assist in the submission of expedited single cases to Health Canada. Collection, follow-up and forwarding of spontaneous, literature, solicited, post-marketing adverse event cases, ensure local safety data quality control. Assist in the Planning and Processing of Aggregate Reports.
  • Assist in the Preparation and Implementation of new and updated PV Agreements.
  • Support PV Awareness and Training. Assist in the development and maintenance of PV SOPs.
  • Assist in PV Audit and Inspection Readiness.

Complaints and Queries:

  • Coordination of Complaints/Adverse reactions/Queries, with relevant departments (e.g. Regulatory, QA, Customer Service, Export, PV third party vendor) in order to help compile adequate feedback to patients and healthcare professionals, as well as redirect and process adverse events cases, as appropriate.
  • Perform other duties as assigned by supervisor.

Requirements – Academic, Experience

Education: M.Sc. degree in health Science disciplines.  DESS in Regulatory Affairs a definite asset.

Experience: 1-2 years' experience within the pharmaceutical industry, preferably working in Regulatory Affairs, in order to be able to work as independently as possible.

Technical Know-How: Familiar with local, regional and any other relevant legislation and guidelines regarding Regulatory (e.g., Health Canada, ICH, USP) and PV (e.g. Health Canada), in order to fulfill duties.

Other Criteria

  • Fluency in French and English, written and oral.
  • Computer literacy and working knowledge of MS Office suite and PDF editor.
  • Management skills.
  • Excellent communication skills.
  • Results and quality oriented, and sense of urgency: Ability to review relevant source documentation with attention to detail and accuracy, while managing multiple tasks and prioritizing work in order to meet strict deadlines. 
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