Regulatory Affairs Specialist

1 week ago


Laval, Quebec, Canada Bausch Health Full time

Bausch Health is a leading international pharmaceutical company dedicated to delivering high-quality health and wellness products to Canadians.

About the Role

We are seeking an experienced Regulatory Affairs Specialist to join our team in Canada. The successful candidate will have a strong working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products.

Key Responsibilities:
  • Prepare and compile submissions for Health Canada in eCTD format to obtain marketing authorization for new products and maintain conformity and life cycle of currently marketed products.
  • Plan, manage, and coordinate the preparation, compilation, filing, and approval of regulatory submissions for presentation to Health Canada.
  • Critically assess data and documents to identify gaps compared to regulatory requirements and elevate key areas of regulatory risk.
  • Maintain and ensure regulatory product compliance. Interact, communicate, and negotiate with internal and external stakeholders including Health Canada.
  • Prepare and review responses to Health Canada letters (Notice of Non-Compliance, Notice of Deficiency, and Clarifaxes) in a timely manner.
  • Assist in the review and coordination of French translations of Product Monographs and product labeling.
Requirements:
  • University Degree, B.Sc. or higher (Master's degree or a PhD) in Health Sciences. A DESS in Drug Development and/or a RAC certification is an asset.
  • Minimum 5 years of relevant experience in Canadian Pharmaceutical Regulatory Affairs, with recent solid experience in managing drug products, natural health products, and medical device licensing.
  • Excellent organizational and communication skills (oral and written).
  • Bilingual (English and French).
  • Ability to prioritize projects, coordinate multiple projects simultaneously, and work with tight deadlines.
  • Computer Literacy – Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat.

The estimated annual salary for this role is approximately $120,000 - $150,000 CAD, depending on qualifications and experience.



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