Introduction to Pharmaceutical Regulatory Affairs
Issued on 15 May 2026 by
Seneca Polytechnic
This training provides learners with practical, job ready knowledge of pharmaceutical regulatory affairs in Canada, using Health Canada as the core regulatory reference. Participants gain hands on experience navigating drug legislation, preparing regulatory submissions (including CTD and eCTD components), and understanding pre and post market regulatory responsibilities. Ideal for those aspiring to work in regulatory affairs, quality, or compliance roles within the pharmaceutical and life sciences sectors.
Issuer
Seneca Polytechnic
info@senecapolytechnic.ca
Seneca Polytechnic is a multiple-campus public college located in the Greater Toronto Area of Ontario, Canada. It offers full-time and part-time programs at the baccalaureate, diploma, certificate and graduate levels.
Criteria
The recipient of this digital badge has demonstrated competency in:
- Interpreting and applying the Food and Drugs Act and Food and Drug Regulations
- Navigating Health Canada guidance documents and regulatory pathways
- Preparing components of Common Technical Documents (CTD/eCTD) for drug submissions
- Understanding Chemistry, Manufacturing, and Controls (CMC) requirements
- Applying Good Manufacturing Practices (GMPs) in regulatory contexts
- Managing pre and post approval regulatory submissions
- Understanding regulatory requirements for clinical trials, safety reporting, and adverse reactions
- Recognizing regulatory considerations for generic drugs, biologics, medical devices, cannabis, and orphan drugs
- Assessing the regulatory impact of drug advertising and post market changes
And demonstrated competency in the above by:
Presenting on a regulatory requirement, submission pathways. Different aspects of the regulations not covered above.
