Regulatory Compliance Manager

2 months ago

Laval, Quebec, Canada Bausch & Lomb Full time
Job Description

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 that are distributed across the country.

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with Canadian regulatory guidelines and regulations.

Key Responsibilities:
  • Regulatory Submission Management: Prepare and compile regulatory submissions to Health Canada in eCTD format, ensuring compliance with Health Canada's guidelines and regulations.
  • Regulatory Compliance: Maintain and ensure regulatory product compliance, interacting with internal and external stakeholders, including Health Canada.
  • Regulatory Risk Management: Identify and mitigate regulatory risks, ensuring that our products meet the required regulatory standards.
  • Communication and Collaboration: Communicate effectively with internal stakeholders, including cross-functional teams, to ensure seamless regulatory submission and compliance processes.
  • Regulatory Knowledge Management: Maintain current awareness of all regulatory guidelines, including Health Canada Guidance Documents and ICH.
Qualifications:
  • Education: 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.
  • Experience: Minimum 5 years of relevant experience in Canadian Pharmaceutical Regulatory Affairs, with recent (2-3 years), solid experience/expertise in managing drug products (Rx, Ethical, DIN-OTC), natural health products (NPN) and medical device licensing (if applicable).
  • Skills: Strong working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products (drug products and medical devices). Excellent organizational and communication skills (oral and written). Bilingual (English and French).

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

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