Regulatory Affairs Specialist

5 days ago

Laval, Quebec, Canada Bausch & Lomb Full time
Regulatory Affairs Specialist

Bausch Health Canada is a leading pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.

Key Responsibilities:
  • Plan, manage, and coordinate the preparation, compilation, and approval of high-quality regulatory submissions for presentation to Health Canada in eCTD format.
  • Prepare and review responses to Health Canada letters in a timely manner, ensuring prompt regulatory approvals of dossiers under review.
  • Evaluate change controls, determine necessary requirements, and prepare and compile L3 submissions to maintain product conformity and lifecycle.
  • Critically assess data and documents to identify gaps compared to regulatory requirements.
  • Maintain and ensure regulatory product compliance, interacting with internal and external stakeholders like Health Canada.
  • Stay current with regulatory guidelines (Health Canada, ICH, etc.)
  • Support the Sr. Manager RA-CMC as necessary.
Qualifications:
  • University Degree, B.Sc. or higher, in Health Sciences, with a DESS in Drug Development and/or RAC certification an asset.
  • Relevant Quality Assurance/Compliance experience and CMC experience in Canadian Pharmaceutical Regulatory Affairs.
  • Strong working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products.
  • Excellent organizational and communication skills, with bilingualism (English and French) a requirement.
  • Ability to prioritize projects, coordinate multiple projects simultaneously, and work with tight deadlines.
  • Entrepreneurship, focus on customer needs, and good business acumen.
  • Computer Literacy – Microsoft Package, Adobe Acrobat, Veeva, Docubridge, Trackwise.

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