What a regulatory affairs specialist does
Regulatory affairs specialists prepare and manage the submissions a company needs to sell health products in Canada. Depending on the product, that might be a new drug submission or a generic drug filing, a medical device licence application, a natural product number application or a cosmetic notification. They also maintain product monographs and labelling, file post-approval changes, answer Health Canada questions and track guidance updates that affect the business. A missed requirement can delay a launch or take a product off shelves.
Regulatory experience rarely transfers neatly between product types. A specialist who has filed generic drug submissions may know little about device classification, and natural health product work is its own discipline. Finch starts by learning which products, markets and submission types you handle, then looks for specialists with matching hands-on filings. Many regulatory roles in Canada are hybrid or remote, so we search across the country as well as in the GTA and present candidates whose experience fits your pipeline.
Typical responsibilities
- Prepare and compile drug, device or natural health product submissions to Health Canada, often in eCTD format
- Review labels, product monographs, advertising and packaging for regulatory compliance
- File post-approval changes, notifications and licence amendments
- Respond to Health Canada screening and review questions within set deadlines
- Advise product development and marketing teams on regulatory requirements
- Monitor new regulations and guidance and assess their impact on the product portfolio
Qualifications and credentials
- A degree in pharmacy, life sciences, chemistry or a related field; many employers also value a post-graduate regulatory affairs certificate
- Hands-on experience with the Food and Drug Regulations, the Medical Devices Regulations or the Natural Health Products Regulations, depending on the product
- Regulatory Affairs Certification (RAC-Drugs or RAC-Devices) from RAPS, which employers often prefer but rarely require
- Experience with submission publishing and electronic document management systems
- French language skills for bilingual labelling review, where the role calls for it
Who hires a regulatory affairs specialist
- Brand-name and generic pharmaceutical companies
- Medical device manufacturers and distributors
- Natural health product and cosmetic companies
- Regulatory consulting firms
- Contract research and contract manufacturing organizations
Where we recruit regulatory affairs specialist candidates
We fill regulatory affairs specialist roles for employers across Toronto and the GTA, including North York, Scarborough, Etobicoke, Vaughan, Markham, Richmond Hill, Mississauga, Brampton, Oakville, Burlington, Oshawa and Pickering, and for employers across Canada. GTA employers can meet us at our North York office by appointment.
What Finch checks before you meet a candidate
- Map the submission types the candidate has prepared and the product classes they know
- Confirm their role on past filings, from document author to submission lead
- Check RAC or other credentials with the issuing body
- Discuss how they handled a Health Canada deficiency or clarification request
- Speak with references about accuracy under submission deadlines
Interview questions to ask
- Tell me about a submission that drew questions from Health Canada. How did you build the response?
- How would you assess whether a change to our product needs a filing, a notification or only internal documentation?
- Which guidance documents do you follow most closely, and how do you keep up when they change?