Regulatory Affairs Specialist

1 month ago


Laval, Quebec, Canada Bausch & Lomb Full time
Job Title: Senior 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 that are distributed across the country.

Key Responsibilities:
  • Prepare and compile regulatory submissions to Health Canada in eCTD format, ensuring compliance with guidelines and regulations.
  • Plan, manage, and coordinate the preparation, compilation, and approval of high-quality regulatory submissions.
  • Critically assess data and documents to identify gaps and regulatory risks, and elevate key areas for attention.
  • Maintain and ensure regulatory product compliance, interacting with internal and external stakeholders, including Health Canada.
  • Prepare and review responses to Health Canada letters, ensuring timely and accurate communication.
  • Assist in the review and coordination of French translations of Product Monographs and product labeling.
  • Negotiate with Health Canada to ensure prompt regulatory approvals of dossiers under review and in preparation.
  • Liaise with internal and external groups to collect necessary documents and information, providing regulatory support.
  • Maintain current awareness of all regulatory guidelines, including Health Canada Guidance Documents and ICH.
  • Internal regulatory review of promotional products for branded pharmaceuticals.
  • Review of Change Controls and determination of filing requirements.
Qualifications:
  • University Degree, B.Sc. or higher, in Health Sciences, with a DESS in Drug Development and/or RAC certification an asset.
  • Minimum 5 years of relevant experience in Canadian Pharmaceutical Regulatory Affairs, with recent experience in managing drug products, natural health products, and medical device licensing.
  • 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, good business acumen, and a sense of urgency, with agility and flexibility.
  • Computer literacy, including Microsoft Package and Adobe Acrobat.


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