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SteriMax Regulatory Coordinator

1 week ago

Oakville, Ontario, Canada SteriMax Inc. Full time

We are seeking a talented Regulatory Affairs Associate to join our team at SteriMax Inc.

About the Role

The Regulatory Affairs Associate will be responsible for preparing regulatory submissions for generic drug products and managing submissions under regulatory agency review.

Main Tasks:

  1. Develop and implement regulatory strategies to ensure compliance with Health Canada regulations.
  2. Prepare and submit regulatory documents, including generic injectables and complex generics.
  3. Collaborate with internal teams to ensure seamless product supply and quality control.
  4. Conduct RA impact assessments and provide recommendations for improvement.
  5. Maintain up-to-date knowledge of Health Canada and ICH regulatory guidelines.

Requirements:

  • Bachelor's degree in a related field.
  • Minimum 3 years of experience in regulatory affairs.
  • Excellent communication and project management skills.
  • Strong understanding of regulatory policies and procedures.