Regulatory Operations Manager
Sector: Health Science
Type: Career Profile
Biology, Chemistry, Health
I enjoy interacting with members of my team (present in U.S, Canada and Europe) and it is interesting to learn about their local regulations/processes and at the same time, share Canadian knowledge with them.
This is not what I expected to be doing when I graduated from high school. In fact, I didn't know this job existed until I was volunteering with the provincial government and someone mentioned regulatory affairs to me.
When I graduated with my Bachelors of Science, I worked at different jobs in the retail sector. In these jobs, I worked with customers and developed my customer service skills. I worked with teams of people where I strengthened my time management and interpersonal skills. When I learned about regulatory affairs, I went back to school and earned a certificate in regulatory affairs. The regulatory affairs graduate certificate program teaches the knowledge, skills and techniques which you need to work in regulatory affairs in the pharmaceutical, medical device or biotechnology industries. In this program, I developed my knowledge of the regulatory system, legislation, procedures and practices, which relate to the development, manufacture, quality assurance and marketing of health-related products.
Then I started work with companies where I used my regulatory affairs skills. My first roles were at the entry level but as I further developed, I took roles that were more senior. As these roles became more involved and complex, I continued to grow my understanding and skills in managing large and complex projects. Eventually I completed a Certificate in Project Management, which I draw upon every day in my current position.
If you are interested in a career in regulatory affairs, take business courses in school, network and find a mentor.
I love spending time at the cottage, and travelling (Nashville, California). I practice kickboxing. I also volunteer in a Children's clinic in North York.
On a day-to-day basis a lot of my work involves making sure the documentation we submit to Health Canada follows the proper procedures and contain the necessary information. I make sure procedures are in place so that we can process both incoming and outgoing documentation. This means I have a lot of face to face meetings as well as a lot of email to keep up on. I use a variety of software tools to put our documents together. Part of my role is to manage the creation and submission of the necessary documents making sure they follow regional regulations and timelines. By making sure we follow the appropriate regulations and guidelines, I help make sure our drugs get to market as soon as possible.
When I was
- Brought People Together
- Enjoyed doing things on my own
- Liked helping people
- Played on a sports team
- Was motivated by success
- Wanted to be in charge
- Liked being given specific instructions
- Engaged in volunteer activities
- Liked reading
- Felt great satisfaction in getting good grades
- Wasn't sure what I wanted to do
- Learned Best by Doing