Job of the future

Regulatory Affairs Specialist

November 11, 2021
Duration: 03:33

The regulatory affairs specialist is the contact person for regulations and standards and is responsible for managing dealings and relationships with regulatory bodies. In this role, the individual ensures regulatory follow-up of products, processes and technologies, their registration and ensures their compliance.

Main duties

1. Perform regulatory monitoring of a product, process or technology under development

2. Develop and implement regulatory strategies

3. Prepare regulatory files and ensure that the documentation filed with regulatory authorities is compliant

4. Provide regulatory support to the organization

5. Ensure regulatory oversight

Academic training


Undergraduate studies

Bachelor of Biology

Bachelor of Biological sciences

Bachelor of Biochemistry

Bachelor of Biochemistry and molecular medicine

Bachelor of Biomedical sciences

Bachelor of Biopharmaceutical sciences

Bachelor of Microbiology and Immunology

Bachelor of Neuroscience

Bachelor of Engineering in Bioresource Engineering


Graduate studies (An asset)

Master’s degree in pharmaceutical sciences 

Master’s degree in Drug Development  

Master’s degree in health technologies assessment

Master’s degree in drug and population health

Master’s in Biology

Master’s in Biological sciences

Master’s in Biomedical sciences

Master’s in Biochemistry

Master’s in Pathology and Cellular Biology

Master’s in Molecular Biology

Master’s in Molecular, Cellular and Integrative Physiology

Master’s in Microbiology and Immunology

Master’s in Neuroscience

Master’s in Bioresource engineering

Master’s in a related field

Specialized graduate diploma in drug development

Specialized graduate diploma in Health technology assessment

Specialized graduate diploma in toxicology and risk assessment

Specialized graduate diploma in clinical biology

Short graduate program (Master’s level) in health technology asessment

Short graduate program (Master’s level) in health technology assessment  

Short graduate program (Master’s level) in Pathology and Cellular Biology


Postgraduate studies (An asset)

Ph.D in pharmaceutical sciences

Ph.D. in Biology

Ph.D. in Biological sciences

Ph.D. in Biomedical sciences

Ph.D. in Molecular Biology

Ph.D. in Molecular, Cellular and Integrative Pathology

Ph.D. in Biochemistry

Ph.D. in Microbiology and Immunology

Ph.D. in Virology and Immunology

Ph.D. in Neuroscience

Ph.D. in Bioresource engineering

Ph.D. in a related field

Hiring sub-sectors

Innovative Pharmaceuticals
Contract Manufacturing Organizations (CMOs)
Contract Research Organizations (CRO)
Medical Technologies
Health IT / AI
Natural Health Products

Profile of required skills



  • Master the product life cycle
  • Technical writing
  • Know the regulations (SC, FDA, EMA)
  • Know the production/manufacturing standards (ISO)
  • Ensure regulatory oversight
  • Master the different steps involved in the regulatory processes
  • Have the ability to influence
  • Be proficient in negotiating techniques
  • Develop and maintain a network
  • Bilingual
  • Manage priorities
  • Be familiar with the economic environment
  • Take an interest in research development
  • Understand Canada’s health care system
Regulatory Affairs Specialist

Industry opportunities

Prospects – Findings

Profile sought:

  • Work experience in the area of LSHT regulations
  • Network or connection with regulatory organizations
Salary range