Name: Debbie Bonello
Born: Kapuskasing, Ontario
Profession: Regulatory Affairs
Ever stop to think how a pharmaceutical or medical product finally makes it to the shelves of your local drug store? Who makes sure they’re safe? Who makes sure they meet government regulations and standards? Who handles complaints from customers about side effects or issues a recall on a product? That’s where Regulatory Affairs comes into play. Debbie Bonello speaks about what being a Regulatory Affairs Associate is like.
What is a Regulatory Affairs Associate?
A Regulatory Affairs Associate does a lot of pre-market approval of health care products and keeps an eye on them after they hit the market – something called post-market surveillance. In my case, it means making sure that medical products sold by our company are licensed with Health Canada, so that involves appropriate formulation, safety studies, efficacy data, and clinical study reports. Once Health Canada reviews it to make sure it is safe for Canadians, we put it on the market.
What are some issues you have to deal with after the product is on the market?
After you’ve worked to get a drug approved for the market, you're still responsible to make sure it's a high-quality and safe product. Post-market surveillance is mostly complaint handling, product recall and adverse-event reporting. In the case of an adverse event, for example someone having a reaction to the product, it's my job to make sure that the reaction is not because of a misproduction or mislabeling of the product. All of this has to be done in conjunction with the rules and regulations set out by Health Canada.
What is a typical day like for you?
I come in to a pile of emails and voice mails, because we support products globally, so many people are up working in different time zones. I usually come into inquiries from Europe, so I first answer those, then attend business meetings in project planning to make sure that all of the company plans are taking the regulatory requirements into consideration with bringing new products to the market, and with advertisements.
What role do you play in a product’s advertising?
I review product packaging and product materials before it goes on the market to ensure it’s correct and to make sure that the labels and materials accurately reflect how the product performs, and how it was licensed for sale in Canada. Advertising is authorized by Health Canada, so it's important to get it right.
What music do you have in your mp3 player right now?
Mix of rap and hip hop
Did you always want to be a Regulatory Affairs Associate?
I never even knew what it was! I actually wanted to go into forensic science. I started off in this field at an entry-level position in the corporate lab doing product testing. An opportunity became available for a short-term replacement in regulatory affairs. I just sort of fell into it, and it was love at first sight.
What courses in high school prepared you for this field?
Organic chemistry and human biology.
Would you rather smell intensely of raspberries or be blue like a Smurf?
I'd rather be blue like a Smurf because Smurfette always had great shoes!
Where did you go to university?
I went to the University of Western Ontario (UWO) and graduated with a Bachelor of Science degree.
How did you decide where to go?
I went by a recommendation from a high school chemistry teacher who used to be a professor at UWO.
Meat. Yes or no?
Yes, definitely meat.
Was there extra training required for this career after you finished university? If so, what?
Yes, although not formally. Most of it is through going to conferences, keeping current on changing rules and regulations, and on-the-job training.
What is the coolest part of your job?
The coolest part of my job is when I receive an approval for a product that has been under review. When that product becomes available and will make a difference in the lives of Canadians, it's such a great feeling! It's also fun to go to the drugstore and see a product in which I was instrumental in its creation. I think, "I signed off on that packaging!"
What country would you most like to visit?
Italy or Spain
What's the worst part of your job?
The worst part of my job is having to say “no” a lot. In regulatory, we get referred to as the “sales prevention team”. We have to provide other options to a lot of people within the company. At the end of the day, it's product safety that's most important.
Ooooops! Everyone makes mistakes so what was the dumbest thing you've ever done at work?
In my first six months on the job, I was asked to coordinate label changes for a mandatory statement that needed to be added to pesticide labels, and I made them for the wrong product! Luckily a co-worker caught it in time!
What celebrity do you most resemble?
Meryl Streep and Beverly D'Angelo
Any advice that you would give others seeking a similar career?
It's never boring. There's always something challenging. It's growing, it's ever-changing.
What's your zodiac sign?
What are some great web links or references for someone interesting in reading up more about this career?
Regulatory Affairs Professional Society
Canadian Association of Professional Regulatory Affairs
Thank youi Erin Isings for conducting this interview.