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Team Spotlight: Regulatory Affairs 

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If you’re looking for a team at Foundation Medicine with a cross-functional reach, you need not look any further than the Regulatory Affairs team. The team serves a critical role as a collaborative, results-driven partner, driving development and supporting the launch of transformational products, as well as influencing the global regulatory and policy environment in which they operate. The Regulatory Affairs team is situated at the intersection of many aspects of the business, including laboratory operations, research and development, technology, commercial, and legal functions. They offer key insights, strategy, and support to bring our products to market, serving our patients, physicians, and research partners both in the U.S. and in ex-U.S. markets.

Performing a critical function throughout a product’s lifecycle, Regulatory Affairs leads pre-market strategy, drafts regulatory submissions, and ensures post-market compliance for Foundation Medicine. “When I first joined the team about five years ago, there were only three or four people on the team, and now we’re a team of over 20,” explained Juan, Associate Director, Regulatory Affairs. “Now, with a larger team, we work on even more than companion diagnostic (CDx) approvals or licensure. We partner with biopharma companies and work on platform improvements to ensure we have state of the art products on the market, among other things,” she continued.

At Foundation Medicine, there is a focus on including our Regulatory Affairs team from the very beginning of our product development processes. “We’re heavily involved from a product strategy standpoint from the beginning, and I think that’s key,” shared Varun, Director, Regulatory Affairs. “It shows that firstly, there’s an appreciation for regulatory affairs in the organization, but it also shows that the organization is thinking about what it takes to demonstrate the high quality of our products for physicians and patients.”

 

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The regulatory affairs team’s primary remit is the final step of getting and keeping our products on the market. Being involved from the beginning ensures a more effective and optimized process that prioritizes our patients and partners.

The team works hard to enable patient access to improved and novel platforms through their support of the development and launch of our transformational products. “Our products are also available in many countries outside of the United States,” explained Juan. “We need to make sure that we are compliant with the regulatory bodies in those countries, especially because the field of companion diagnostics is still new and evolving in many places,” she added.

They also collaborate to influence the regulatory and policy environment, interacting with the U.S. Food and Drug Administration (FDA) and other regulatory agencies worldwide. “We are a liaison between our scientific teams and different regulatory bodies, like the FDA,” explained Melissa, Senior Regulatory Affairs Specialist. “A lot of what we do isn’t very black and white. We get to be creative and innovative while meeting regulations and compliance standards,” added Varun. 

Because of their broad reach and collaborative nature, the team is constantly striving for improved processes and operational excellence. “We listen to input from a variety of people – and often, they have different ideas of how things should be done,” shared Melissa. “We need to be able to see their perspective and assuage their concerns."

 

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The feedback that the team gathers comes from both internal and external partners, and because they often sit on the cutting edge of the regulatory field, problem solving as a team is key. “We grow a lot closer through collaborating and thinking through requests from our partners to ensure everyone is happy with the result,” explained Alyssa, Manager, Regulatory Affairs. “Sometimes there is an education component of that, where we need to explain that there is a different way a process should be done from a regulatory perspective,” she added. “One of the best experiences is making it through our projects and feeling a sense of accomplishment when we’ve been able to take everyone’s feedback into account.” 

Regulatory Affairs team members pride themselves on their ability to sit with the unknown and work together to come up with a solution that benefits all of their stakeholders. The process, they say, at times can be a challenging one, but in the end, providing creative and successful solutions as a team is impactful and exciting.

“I could go on about how many times we’ve been one of the firsts in terms of regulatory approval for a particular therapy type or biomarker. It’s just really exciting to be a part of that,” added Varun. “I think the key part of that is not just the cutting-edge nature of our work, but also the teamwork behind it to strategize and identify how we can best work together with our internal and external partners to find the right path for our products.”

The team has grown in 2022 and continues to grow as the scope of their work expands. The mission-centric approach and the opportunity to work in a cutting-edge field has attracted employees with a wealth of knowledge and a variety of backgrounds. “It’s nice to work for a company that you can be proud of when you tell people what the mission is,” explained Melissa. “A lot of us are fairly new to the company, but the way we’ve come together to share information and learnings and to make it a team atmosphere has built cohesion and support.”

 

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The Regulatory Affairs team looks forward to continuing to function as an agile world-class organization, negotiating successful solutions with health authorities and providing measurable value to our patients, clinical partners, and internal colleagues. As our products evolve, so will the team, ensuring the safety and effectiveness of Foundation Medicine’s offerings throughout their entire lifecycle.

To learn more about open roles on the team, click here.

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