How a Moderna co-op made a regulatory affairs career in Canada real

How a Moderna co-op made a regulatory affairs career in Canada real

Yash Shah was up against a deadline when it clicked: this wasn’t just a classroom exercise. The work supported the regulatory compliance for products marketed in Canada.

For Shah, an MS in Regulatory Affairs student at Northeastern University in Toronto, the moment marked a shift in perspective as he settled into his co-op with Moderna’s quality team in Laval, Que.

“That was the moment it stopped feeling like an internship and started feeling like I was genuinely part of the Canadian healthcare system, with a small but real role in keeping it running,” Shah says. “Coming from a different country and a different regulatory world, that meant a lot.”

It was a realization that would go on to define his experience at one of the world’s leading biotechnology companies — and set the tone for the impact he would have throughout his co-op.

The question that shaped a career path

After earning a degree in biomedical engineering, Shah began his career selling ultrasound machines to hospitals and clinics across Mumbai. When he eventually moved into a clinical applications role, training healthcare professionals to use the equipment, Shah found himself returning to the question that would shape his career path.

How does a medical product actually get approved in the first place?

“That question pulled me into regulatory affairs,” says Shah, who spent the next seven years in regulatory affairs for global medical device clients. “The deeper I got, the clearer it became that regulation isn’t just paperwork at the end of the process. It’s what determines whether a product reaches a patient at all. That’s why I went back to school. I wanted to understand the system as a whole, not just my corner of it.”

Shah decided to deepen his understanding of the field by pursuing a master’s degree. Because much of his professional growth had come through hands-on experience, he was drawn to Northeastern University’s experiential learning model and enrolled in the MS in Regulatory Affairs program in Toronto in 2025.

“At Northeastern, you don’t sit through two years of theory and hope it translates later,” he says. “You work inside a real company while you’re still studying. The co-op was a major reason I chose Northeastern over other options.”

How a Moderna co-op turned classroom into practice

With co-op as a central goal of his master’s experience, Shah worked closely with Northeastern University’s experiential learning specialists and career services team. Resume coaching, interview preparation, and tailored career guidance were all part of his co-op preparation process.

“The Toronto campus team and career services helped me retool how I present myself for the Canadian market, which is genuinely different from how I pitched myself in India,” he says. “Landing a regulatory co-op at Moderna felt like proof that the work paid off. For someone who was effectively starting over in a new system, that placement meant a lot.”

After relocating to Quebec and starting his co-op, Shah quickly began contributing to projects supporting Moderna’s regulatory compliance in Canada. His work spanned drug establishment licence maintenance, quality documentation, and training program improvements. Of those projects, he says the annual licence review had the greatest impact.

Where regulatory work became real

The process helps ensure that the information Moderna maintains with Health Canada is accurate and up to date, supporting the company’s ability to keep products compliant and available on the market. Shah was responsible for reviewing detailed product records, identifying discrepancies, and supporting documentation review activities before routine regulatory updates.

His work required meticulous attention to detail. Shah supported regulatory documentation reviews and helped improve tracking processes to support compliance activities.

“It sounds small, but an error in that paperwork can stall compliance,” he says. “The moment my coursework clicked was realizing I wasn’t just catching typos. I understood why annex accuracy matters, how it ties back to what was originally approved, and what’s at stake if it’s wrong. The regulatory frameworks I studied gave me that mental model.”

The project also gave Shah a firsthand look at how regulatory submissions move through the system. For the first time, he saw how companies work with Health Canada, how filings are assembled, and what regulators expect to see.

“School teaches you what a submission is,” he says. “Doing it teaches you how it lands on the other side.”

Confidence in what’s next

Marie-Joelle Kabrite serves as Moderna’s country quality head for Canada. Having worked with Shah during his co-op, she says he approached the placement with qualities that helped him make an impression on her team and succeed in a fast-paced regulatory environment.

“Yash quickly became a valued member of our team through his curiosity, attention to detail, and willingness to learn,” says Kabrite, “Throughout his co-op, he approached each assignment with professionalism and a strong commitment to quality. We appreciate his contributions.”

The co-op also reinforced Shah’s career direction. After graduation, he hopes to pursue regulatory affairs roles within Canada’s pharmaceutical and medical technology industries, with longer-term ambitions of helping shape regulatory strategy.

“The co-op is where everything came together and started to feel like a real future rather than a bet,” he says. “I’m grateful to Northeastern for building a program around real work and to the team at Moderna for trusting a co-op student with work that genuinely mattered.”

By: Izabela Shubair