Job of the future
Regulatory Affairs Specialist
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
College
Pre-university training
Science
- CEGEP de Saint-Laurent
- CEGEP du Vieux Montréal
- CEGEP Gérald-Godin
- CEGEP John Abbott
- Collège Ahuntsic
- Collège André-Grasset
- Collège Brébeuf
- Collège Brébeuf
- Collège de Maisonneuve
- Collège des Marcellines
- Collège du Bois-de-Boulogne
- Collège Marie-Victorin
- Institut Teccart
- Vanier College
Health science
- CEGEP André-Laurendeau
- CEGEP de Saint-Laurent
- Collège Ahuntsic
- Collège Dawson
- Collège de Maisonneuve
- Collège de Rosemont
- Vanier College
- Collège TAV
- Collégiale Sainte-Anne
- Marianopolis College
Pure and applied science
- CEGEP André-Laurendeau
- CEGEP de Saint-Laurent
- Collège Ahuntsic
- Collège Dawson
- Collège de Maisonneuve
- Collège de Rosemont
- Vanier College
- Collégiale Sainte-Anne
- Marianopolis College
Scientific French Baccalaureate
Technical training
DEC, AEC: /
University
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
- Université de Montréal
- McGill University (Thesis)
- UQAM
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
- McGill University (Thesis)
- McGill University (Non-Thesis)
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
Continuous training
Hiring sub-sectors
Profile of required skills
TECHNOLOGICAL
n.s.p.
SCIENTIFIC
- Master the product life cycle
- Technical writing
REGULATIONS AND STANDARDS
- Know the regulations (SC, FDA, EMA)
- Know the production/manufacturing standards (ISO)
- Ensure regulatory oversight
- Master the different steps involved in the regulatory processes
RELATIONSHIPS AND SALES
- Have the ability to influence
- Be proficient in negotiating techniques
- Develop and maintain a network
MANAGEMENT
- Bilingual
- Manage priorities
BUSINESS INTELLIGENCE
- 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