roche, blog, canada

Meet Nives

Tell us a bit about yourself.

I started my career in vaccine manufacturing after studying Biochemistry at Ryerson University in Toronto. This is where my passion for drug manufacturing started. After a few years, I moved to an R&D biotech company, where my knowledge of antibody development broadened. Here, I worked on generation of antibodies from tissue culture, antibody purification, quality control and assay development. After a number of years in R&D, I decided to switch gears and join the regulatory field, still keeping with my love of science and drug manufacturing – and as such, a role in Chemistry Manufacturing and Controls (CMC) regulatory seemed like a perfect choice. I joined Roche Canada Regulatory Affairs CMC team as an Associate, working on regulatory filings for many Roche products. In 2015, I became the CMC Group Manager and interacted closely with local and global Roche functions as well as Health Canada.

What is your current position at Roche Canada?

I recently became a Group Manager as part of a Global Pharma Technical Regulatory (PTR) function within Roche Canada, a new function for our Mississauga site. PTR develops global technical regulatory strategies for products in development and on the market, and produces CMC documents for submissions to health authorities all across the globe. PTR also works with health authorities when they develop regulations.

How would you describe Roche as an employer?

Roche fosters a very flexible, open and collaborative culture. We’re able to work from home when needed, choose to work within different spaces in the building, as well as having the opportunity to give back to the community in the form of volunteer opportunities.

How does your work contribute to Roche?

My work helps Roche to provide guidance on health authority expectations and regulations to support innovative science, and to allow new technologies and scientific approaches to be taken. We are demonstrating to the health authority that we manufacture quality product for our patients.

What would you advise job seekers who want to join us?

If you’re looking for a place where you will continuously learn and be challenged, then this is a place for you. There is great emphasis on developing the potential in people and giving recognition for a job well done.

What can you tell us about the current job openings?

Our newly established PTR team in Mississauga is still growing. Roche has an exciting pipeline, and we are looking for individuals to provide global regulatory guidance and high-quality CMC submissions. We are seeking regulatory professionals with strong skills who are interested in forming technical regulatory strategies and wanting to be part of a dynamic, hardworking team.

Tags: Career Blog, Canada