Regulatory Affairs Associate

6 days ago


Oakville, Ontario, Canada SteriMax Inc. Full time

At SteriMax Inc., we are seeking a highly motivated and detail-oriented Regulatory Affairs Associate to join our team. As a key member of our regulatory affairs team, you will be responsible for preparing regulatory submissions for generic drug products and actively participating in the management of submissions under regulatory agency review.

Key Responsibilities:
  • Cross-Functional Review and Strategy: Provides cross-functional review and strategy from a regulatory, scientific, and technical viewpoint.
  • Submission Preparation: Coordinates the assembly, including requesting and/or generating, of documents to support submissions including generic injectables, and may also include complex generics and biosimilars per established business processes and systems.
  • Liaison with Partners: Liaises with partners to collect documents and information for submission preparation or in response to technical queries/deficiency letters.
  • Labelling Activities: Executes labelling activities, preparing the product monograph and coordinating the generation of mock-up artwork with senior artwork specialist.


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