Regulatory Affairs and Pharmacovigilance specialist

October 4 2019
Industries Pharmaceutical, Biotechnology
Categories Pharma, Biotech, Sciences, R&D, Scientific and Regulatory affairs, Quality assurance and control, Validation, Pharmacovigilance
Laval, QC

Main Tasks:

  • Assessment of products formulations according to Canadian regulations;
  • Development of regulatory strategies;
  • Preparation and submission of Product Licence Applications (PLA) for NHP and DIN;
  • Preparation of New Drug Submissions (CTA, NDS, SNDS, ANDS);
  • Preparation and submission of Site Licence and Establishment Licence Applications;
  • Writing and/or review of cosmetics, NHP and DIN labels;
  • Communication with Health Canada and follow-up on clarifaxes;
  • Receipt and evaluation of the adverse events reports, writing of the CIOMS;
  • Review and preparation of the pharmacovigilance annual reports.

Requirements:

  • Bachelor degree in a medical science or related field;
  • Minimum of five years related experience;
  • Knowledge of the Canadian regulations for cosmetics, NHP and drugs;
  • Knowledge of the eCTD applications and of Lorenz DocuBridge;
  • Ability to work under minimal supervision (Tele-working) and to manage multiple priorities;
  • Excellent written and oral communication skills in English and French.
Apply now!

Jobs.ca network

#