Pharmaceutical Regulatory Affairs and Quality Operations Grads
Do you remember a time you thoughtlessly reached into your medicine cabinet for ointment to treat an ailment? Or bit into a piece of cheese? How did you know it was safe? Did it even cross your mind?
Probably not. For that assumption of safety, you can thank a regulatory affairs (RA) and quality operations professional—many of whom receive their training through Seneca’s Pharmaceutical Regulatory Affairs and Quality Operations (RAQC) program.
Regulatory affairs and quality operations professionals work across various industries related to food, pharmaceuticals, self-care and medical devices to protect public health. They do so by controlling the safety and efficacy of products and verifying they are compliant with the standards set out by Health Canada.
“Work in food safety can be quite reactive,” says Alice Gereyhan, Senior Compliance Officer at the Canadian Food Inspection Agency (CFIA) and a recent Seneca graduate. “If a potential food safety issue is identified, we respond very quickly in order to safeguard the public.”
Safety is also a critical component of the pharmaceutical and self-care sectors. They are comprised of companies developing and manufacturing new medicines and therapeutic products that help prevent, alleviate and cure physical and psychological ailments.
The safety and regulation of these products are overseen by people like RAQC graduate Mia Spiegelman, National Director Regulatory Affairs and Quality Assurance at Cardinal Health Canada. Mia’s responsibilities include a 17-person department and overseeing due diligence, quality assurance and licensing of over 100,000 medical devices, drugs and natural health products from 700 suppliers.
She also ensures that all Cardinal distribution centres and services are compliant with the Food and Drugs Act, Good Manufacturing Practices and International Organization for Standardization quality systems requirements. Keeping up with changing legislation requires constant learning.
“You can imagine, if we didn’t do what we do, the number of [product] recalls would be exponential,” says Mia. “Compliance occurs when teams are well-trained, and I have made it a priority to embed ongoing education opportunities into our team’s culture.”
Another RAQC grad, Amanda Wong, got into RA because she wanted to work with products “that help people do more, feel better and live longer.”
In addition to her role as Director, Regulatory Affairs, at GlaxoSmithKline Consumer Healthcare, she has returned to Seneca to teach in the same program that she says was the best decision of her life.
“I love seeing my students graduate from the program and then crossing paths with them at industry events,” says Amanda. “I feel fortunate to be able to help someone build a strong foundation for their career and essentially their livelihood.”
RAQC graduates like Alice, Mia, and Amanda exemplify some of the countless quality assurance and regulatory affair functions that exist across various industries. They work tirelessly to ensure products that consumers depend on are effective and safe. They are the reason you have peace of mind when rummaging through the medicine cabinet or open your refrigerator.
Learn more about Seneca’s Pharmaceutical Regulatory Affairs and Quality Operations graduate certificate program: www.senecacollege.ca/fulltime/RAQC.html
Alice Gereyhan, Senior Compliance Officer at the Canadian Food Inspection Agency (CFIA) and a recent Seneca graduate.