Regulatory Affairs Specialist

Our client is seeking an experienced and dynamic Regulatory Affairs Specialist to join their team. This role will focus on regulatory submissions and quality assurance activities, with a particular emphasis on Natural Health Products (NHPs), supplemented foods, cosmetic products, Site License (SL) amendments, and QA product release under their Quality Importation Services (QIS) division.

Roles and Responsibilities:

• Prepare and submit regulatory applications in compliance with Health Canada requirements, ensuring timely and accurate filings across product categories.
  
• Manage SL amendment applications and updates, ensuring facilities remain compliant with evolving regulatory requirements.
  
• Conduct quality assurance reviews and product release activities for Quality Importation Services, ensuring imported products meet regulatory and quality standards.
  
• Act as a strategic advisor to clients, providing expert regulatory and quality guidance with a focus on efficient, practical solutions.
  
• Communicate with regulatory authorities to address inquiries, resolve issues, and facilitate licensing and product approvals.
  
• Manage multiple client projects and deadlines simultaneously, maintaining high accuracy and responsiveness in a fastpaced environment.
  
• Work closely with internal and external stakeholders to align regulatory and quality priorities with broader business goals.
  
  

• Qualifications:
  

  • Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality Assurance, or a related field.
    
  • Minimum 3 years of regulatory andor quality assurance experience, ideally within a consulting or fastpaced, multiclient environment.
    
  • Strong understanding of Canadian regulations for natural health products, supplemented foods, cosmetics, and site licensing.
    
  • Proven experience preparing and submitting regulatory filings to Health Canada, including SL amendments and product licensing.
    
  • Familiarity with quality assurance processes related to product release, especially within importation frameworks like QIS.
    
  • Excellent written and verbal communication skills, with the ability to explain complex regulatory concepts clearly to clients.
    
  • Demonstrated ability to manage multiple deadlines and prioritize tasks effectively in highpressure situations.
    
  • Clientfocused with strong problemsolving skills and a solutionsoriented approach to regulatory challenges.
    
  • Comfortable working collaboratively with internal teams and contributing to a supportive team environment.
    

  • Our client welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. Only applicants meeting the criteria outlined above will be contacted as part of the shortlisting process. All applicants are subject to a criminal, educational, and employment history background check. Must be currently residing in Canada and legally permitted to work in Canada. No phone calls please.
    

    
    

    
    

    
    
    Salary:

    $65,000 $75,000