Regulatory Affairs Specialist

1 week ago

Laval, Quebec, Canada Bausch & Lomb Full time

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

Our team is responsible for manufacturing and marketing a wide range of pharmaceutical and health products distributed across the country.

We invest in our employees and prioritize performance, innovation, and customer satisfaction.

Key Responsibilities:

  • Plan, manage, and coordinate regulatory submissions for Health Canada in eCTD format, ensuring compliance with guidelines and regulations.
  • Prepare and review responses to Health Canada letters, negotiate with regulatory authorities to ensure prompt approvals.
  • Evaluate change controls, determine necessary requirements, and prepare L3 submissions to maintain product conformity and lifecycle.
  • Critically assess data and documents to identify gaps compared to regulatory requirements.
  • Maintain regulatory product compliance, interact with internal and external stakeholders, including Health Canada.
  • Stay current with regulatory guidelines, including Health Canada and ICH.
  • Support the Sr. Manager RA-CMC as needed.

Qualifications:

  • University degree in Health Sciences or related field, with a Master's degree or PhD preferred.
  • 3-4 years of relevant CMC experience in Canadian Pharmaceutical Regulatory Affairs, with experience in managing drug products and lifecycle.
  • Strong working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products.
  • Excellent organizational and communication skills, with proficiency in Microsoft Office and Adobe Acrobat.
  • Bilingual (English and French) with ability to prioritize projects, coordinate multiple projects simultaneously, and work with tight deadlines.
  • Entrepreneurial spirit, business acumen, and ability to work in a team environment.

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