This article was first published in the Signals blog.
For life science graduates exploring career options, the regulatory affairs function is where scientific expertise meets real-world impact. Regulatory affairs professionals play a crucial role in bringing regenerative medicine – including cell and gene therapies – medical devices and pharmaceuticals to market while ensuring safety and compliance with regulations made by health authorities, such as Health Canada, the U.S. Food and Drug Administration, and the European Medicines Agency.
Last month, Careers Beyond Academia featured two speakers working in regulatory affairs positions in the regenerative medicine and pharmaceutical sectors. The speakers shared insights and advice for people with life sciences degrees who are considering a career outside of academia. Careers Beyond Academia, a virtual series, is hosted by the University of Toronto’s Medicine by Design and the Stem Cell Network.
The session kicked off with introductions of the two speakers. They were:
- Zoe Anderson-Jenkins, Associate Director – Regulatory CMC, BlueRock Therapeutics
- Tracy Porter, Associate Director, Regulatory Strategy, Vertex Pharmaceuticals
In the session, Zoe and Tracy discussed the skills required for working in regulatory affairs and some of the daily functions of their roles. They then divulged helpful tips for scientists considering entering the field. I’ve included some of their key suggestions below.
Top takeaways for aspiring regulatory affairs professionals
Expand your writing skills. Regulatory affairs professionals write many different types of documents that are required by health authorities. However, scientists working in a lab might not yet have experience with the type of writing that’s required in regulatory documents. Prepare for the transition to a regulatory affairs role by expanding your writing skills and technical writing experience, whether it’s for a blog like Signals (thanks for the shoutout Zoe!), or in manuscripts or grants (these Penn University slides are a good resource).
Build and engage your network. Audit your existing LinkedIn connections to see who is working in regulatory affairs. Also, cast a wider net on LinkedIn to find other professionals with regulatory affairs job titles or experience, and determine who in your network could introduce you to them by identifying common connections or organizations. Ask these people to join you for virtual or in-person informational interviews, during which you can learn about their careers (find some tips to guide your interviews here). While this tactic might seem unappealing if it’s a step outside of your comfort zone, Tracy reiterated that people are generally open to informational interviews because they enjoy talking about themselves and helping others, so rest assured that the risk of rejection is low.
Attend industry conferences. Industry conferences and meetings can provide inside information and an opportunity to network with other professionals. Tracy recommended looking for conferences, meetings or other events organized by the Canadian Association of Professionals in Regulatory Affairs, the global Drug Information Association, and the U.S.-based Regulatory Affairs Professionals Society.
Increase your knowledge. If your company or lab has interactions with health authorities, Zoe recommended volunteering to gain exposure to the types of documents that are being prepared for regulators. Even if you’re only able to read previously submitted documents, this is a great way to familiarize yourself with regulatory content and the level of writing that is fit to submit. Further, Tracy suggested doing research to increase your knowledge of the Canadian regulatory and health care systems (and/or other countries/regions, as applicable) and becoming familiar with the processes and steps required to commercialize a product. Some great places to start are:
- Aileen J. Zhou’s 2022 Signals post on the Canadian regulatory system for cell and gene therapies.
- The episode of the Commercializing Living Therapies with CCRM podcast titled “Regulators’ strategies for managing the surge in cell and gene therapies” from February 2024.
- Laya Kiani’s September 2024 Signals post about navigating regulatory challenges and advancements in the regenerative medicine market.
I’ll end the post with a final thought that Tracy shared, which readers should reflect on before diving into a regulatory affairs career path. Someone once told her: “If you enjoy filling out forms and doing taxes, regulatory affairs might be for you!”
