Regulatory Affairs & Compliance (Medicine/Pharma)

Job Brief:

We are looking for two dedicated professionals to join our Regulatory department. As a Regulatory Affairs Officer, you will drive our market authorization strategy for new medicinal products. As a Regulatory Officer, you will manage the essential operational compliance and lifecycle maintenance that keeps our life-saving products on the Canadian market.



Responsibilities:

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  Submission Leadership: Author and compile New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS) in eCTD format.

  
  


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  Clinical Review: Interpret clinical trial data and pharmacovigilance reports to support safety and efficacy claims in dossiers.

  
  


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  Agency Interaction: Act as the liaison with Health Canada’s Health Products and Food Branch (HPFB) to resolve Clarification Requests (Clarifax).

  
  


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  Labeling Compliance: Ensure Product Monographs (PM) and Patient Medication Information (PMI) meet the latest Canadian plain language labeling requirements.

  
  


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  Strategy: Provide regulatory intelligence on evolving Food and Drug Act amendments and their impact on our medicinal portfolio.

  
  

Skills Required:

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  Education: Ph.D., PharmD, or Master’s in Toxicology, Pharmacology, or Chemistry.

  
  


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  Certification: RAC (Regulatory Affairs Certification) is an asset.

  
  


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  Experience: 4+ years in Canadian pharmaceutical regulatory affairs.

  
  


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  Knowledge: Deep familiarity with PAAB (Physician's Advisory Board) and Ad Standards for medical advertising.