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Regulatory Affairs Specialist

2 months ago

Laval, Quebec, Canada Bausch & Lomb Full time
About the Role

Bausch Health is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance of our pharmaceutical products with Canadian regulatory requirements.

Key Responsibilities
  • Plan, manage, and coordinate the preparation, compilation, filing, and approval of high-quality regulatory submissions for presentation to Health Canada in eCTD format and as per Health Canada's Guidelines.
  • Prepare and review responses to Health Canada letters in a timely manner, and assist in negotiations with Health Canada to ensure prompt regulatory approvals of dossiers under review.
  • Evaluate change controls, determine necessary requirements, prepare and compile L3 submissions to maintain the conformity and life cycle of currently marketed products.
  • Critically assess data and documents to identify gaps compared to regulatory requirements.
  • Maintain and ensure regulatory product compliance, interact, communicate, and negotiate with internal and external stakeholders like Health Canada.
  • Maintain current awareness of all regulatory guidelines (Health Canada, ICH, etc.).
  • Support the Sr. Manager RA-CMC as necessary.
Qualifications
  • University Degree, B.Sc. or higher (Master degree or a PhD) in Health Sciences. A DESS in Drug Development and/or a RAC certification is an asset. Relevant Quality Assurance/Compliance experience is also 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. Experience with Biologics is also an asset.
  • 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 of others.
  • Computer Literacy – Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat, Veeva, Docubridge, Trackwise.