Regulatory Affairs Leader – Pharma (Canada)

Recooty; Mississauga; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in Canada seeks dedicated Regulatory Affairs Officers to drive market authorization strategies for new medicinal products. In this role, you will ensure compliance with Canadian regulations and manage operational matters essential for keeping life-saving products in the market. Candidates should have a relevant advanced degree, certification in regulatory affairs is a plus, and a minimum of 4 years' experience in Canadian pharmaceutical regulatory affairs is required.

Qualifications

• A Ph.D., PharmD, or Master's in Toxicology, Pharmacology, or Chemistry is required.
• Certification in Regulatory Affairs (RAC) is an asset.
• Minimum of 4 years of experience in Canadian pharmaceutical regulatory affairs.
• Deep knowledge of PAAB and Ad Standards for medical advertising.

Responsibilities

• Lead the authoring and compilation of New Drug Submissions in eCTD format.
• Interpret clinical trial data and pharmacovigilance reports.
• Act as liaison with Health Canada to resolve Clarification Requests.
• Ensure compliance with Canadian labeling requirements.
• Provide regulatory intelligence on amendments to Food and Drug Act.

Skills

Submission Leadership

Clinical Review

Agency Interaction

Labeling Compliance

Regulatory Intelligence

Education

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

Job description

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.

  
  


• 
  

  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.

  
  


• 
  

  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.