Published: November 28, 2019
Q&A with Michael Balon
The Global Regulatory Affairs, New Product Development team is responsible for the registration of new products to key strategic markets prior to them being sold to various countries. More specifically, they are responsible for compiling dossiers, submitting them to various regulatory agencies, responding to agency queries and ultimately seeing those products through to final approval. The team collaborates with various functional areas of the company – such as research and development, manufacturing, marketing, launch, global intellectual property and others – to compile data and information necessary to complete and submit a high-quality dossier to regulatory authorities.
We spoke with Michael Balon to learn more about his experiences at Apotex and what he looks for in potential candidates.
Describe your journey with Apotex.
I began my career at Apotex as a Quality Control Chemist as part of the APOcampus Program in January 1999. After my eight months as a co-op student in the Quality Control labs, I graduated from the University of Waterloo with a Bachelor of Science with a focus in microbiology. Upon graduation, I was offered a full-time position at Apotex. Twenty years later, I am in the position I am today.
What inspired you to stay at Apotex for 20 years?
To me, the people and the culture associated with the organization are big reasons why I’ve stayed so long as well as the opportunities I’ve been given to learn and progress through more challenging roles. I’ve been fortunate to have had, and continue to have many mentors to guide me throughout my career. I am impressed at the level of collaboration between the teams within the organization working towards the goal of providing high-quality, affordable medications to patients.
Apotex’s purpose is to improve access to medicines for millions of patients worldwide by providing affordable, high-quality solutions. How does the Global Regulatory Affairs, New Product Development team support this mission?
We are in the fortunate position of making a significant contribution to fulfilling the company’s Purpose. When we receive agency approvals for the dossiers we submit, we get licenses to sell our products to countries around the world. We collaborate very closely with many areas of the organization to bring innovative products to the market. Ultimately, by submitting new dossiers for approval, we are helping create and launch innovative solutions.
What is one product you are proud to have had a hand in launching?
One of my favourite achievements was the approval of Mometasone Nasal Spray for the US market. It took Apotex many years to get our approval and it was the first generic nasal spray for this molecule approved in the US. It showed that through collaboration with the FDA and different internal stakeholders at Apotex, we were able to overcome regulatory challenges through the development of new, novel scientific approaches that have never been used before, thus making Apotex a trendsetter in the industry.
What do you enjoy most about coming to work at Apotex each day?
For me, again it would have to be the people. It amazes me the number of experts we have working for our organization. I also take a lot of pride in seeing how the company has grown over the years and the challenges we have overcome. But it’s not just about company growth or personal growth, it’s also about seeing my colleagues grow throughout their career as well. It’s amazing to see the journey that I’ve been on with so many of my colleagues who have been here just as long as myself. I have developed so many positive relationships that I am certain I will maintain for the remainder of my career.
When looking for a candidate, I generally look for people who have a balance of technical capabilities as well as excellent interpersonal skills who are able to work both independently as well as in a team atmosphere. We are looking for people who have an understanding of regulatory affairs, are able to interpret guidelines and apply those to day-to-day problem solving when preparing submissions. As we collaborate with many functional areas within the organization, I believe having excellent communication skills is also very important.
What are some opportunities that potential candidates might have in the Regulatory Affairs group?
The Global Regulatory Affairs New Product Development team offers an individual the opportunity to collaborate with fellow colleagues both within regulatory affairs as well as across the company to prepare high-quality dossiers which ultimately will lead to approval new medicines to be sold around the world. Being on the Regulatory Affairs team and working collaboratively with various internal departments means you get to see what Apotex does as a whole.
As a successful candidate, you would have the opportunity to work on a product from the initial submission all the way to approval and launch of a product. You will be exposed to submissions to key strategic markets. The regulatory landscape is constantly changing, so you are always learning something new. We also offer training programs, hosted by professionals with technical knowledge who can mentor our staff and provide new learnings. We take pride in offering lunch and learn sessions where we can share learnings amongst the team to ensure everyone has the knowledge base to do their job every day.
There are a lot of opportunities to learn new things if you’re willing to put in the effort and show initiative. You will have the ability to learn and grow, showcase your skillsets and develop other skillsets that you may not even realize you are capable of or able to offer.