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.
Pharmacovigilance (PV), in collaboration with third party vendor, as needed:
Complaints and Queries:
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.