Regulatory Affairs Specialist for Canadian Market

hace 2 semanas


Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

ProductLife Group is seeking a highly skilled Regulatory Affairs Specialist to manage post-approval activities in the Canadian market.

The ideal candidate will have experience with regulatory lifecycle maintenance activities, including renewals, change controls, and product information updates. They will also possess knowledge of Canadian regulations for pharmaceuticals, medical devices, and combination products.

A bachelor's degree in a life science-related field is required, along with at least two years of experience in regulatory affairs in the pharmaceutical industry or as a service provider.

In this role, you will be responsible for:

  • Managing post-approval activities, including renewals and change controls
  • Coordinating regulatory submissions and tracking authority approvals
  • Compiling regulatory dossiers and reviewing packaging texts
  • Providing format reviews of Summary of Product Characteristics, Patient Information Leaflets, and labeling

This position requires excellent organizational and interpersonal skills, as well as fluency in English and French. Experience working in a team environment and prioritizing multiple tasks is essential.

We offer a competitive salary, approximately $90,000-$110,000 per year, depending on experience, along with opportunities for professional growth and development.



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