Regulatory Affairs Specialist

1 month 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 needed.
Qualifications:
  • University Degree, B.Sc. or higher, in Health Sciences, with a DESS in Drug Development and/or RAC certification an asset.
  • 3-4 years of relevant CMC experience in Canadian Pharmaceutical Regulatory Affairs, with experience/expertise in managing drug products and lifecycle from a CMC perspective.
  • 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 and focus on customer needs, with good business acumen and sense of urgency.
  • Computer Literacy – Microsoft Package including Word, Excel, and Outlook, Adobe Acrobat, Veeva, Docubridge, Trackwise.

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

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