Regulatory Affairs Specialist

3 weeks ago

Laval, Quebec, Canada Bausch Health Full time

Job Summary:

Bausch Health Canada is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for preparing and compiling submissions to Health Canada in eCTD format, planning and managing the preparation, compilation, filing, and approval of regulatory submissions, and maintaining regulatory product compliance.

Key Responsibilities:

  • Prepare and compile submissions to Health Canada in eCTD format as per Health Canada's Guidelines 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 in a timely manner.
  • Assist in the review and coordination of French translations of Product Monographs and product labeling.
  • Assist in negotiations with Health Canada for prompt regulatory approvals of dossiers under review.
  • Liaise with groups internally and externally to collect necessary documents and information and provide regulatory support.
  • Maintain awareness of all regulatory guidelines (Health Canada Guidance Documents, ICH, etc.).
  • Internal regulatory review of promotional products for branded pharmaceutical products.
  • Review Change Controls and determine filing requirements (Labeling / Clinical).

Qualifications:

  • 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.
  • Strong working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products.
  • 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.
  • Entrepreneurship and focus on customer needs; Good business acumen and sense of urgency; Agility & flexibility; Team player and respect for others.
  • Computer Literacy – Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat.

Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.

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