This week, Associate Director of Regulatory Angela Coy answers the million dollar question, “how does one even break into RA?”

I’ve gotten a lot of questions over the years – from coworkers and from strangers on LinkedIn – about Regulatory and how I found my way into the field. Late last year, I gathered all the advice I’d been sharing and started turning it into LinkedIn posts. I’ve really enjoyed the conversations that followed and the new connections I’ve made. It’s clear there’s a real need for more open dialogue and practical guidance in this space.

I think this is to be expected – Regulatory is a niche field, and there isn’t much information out there, especially the kind that’s actionable.

One of the biggest challenges I’ve seen people face when trying to break into Regulatory is that there is no single playbook. No two paths look the same. In a way, this is great - it means that there is a lot of flexibility. On the other hand, it can come as a shock for scientifically or medically trained professionals who are used to a clear, step-by-step progression: high school → college → advanced degree, with clear requirements to get from one step to the next.

So one of the first things I tell people is this: feeling lost is normal. Feeling uncomfortable is normal. It’s not a sign you’re on the wrong path. Keep going.

Beyond that, there are three things I always recommend to help position your resume for Regulatory:

1.        Regulatory education. This can range from free online courses and certificates to a master’s degree in Regulatory.

2.        Transferable skills. These are capabilities you’ve developed in previous roles that are highly valued in Regulatory, such as technical writing, cross-functional communication, and project management.

3.        Hands-on Regulatory work. This is often the hardest piece, but there is a lot of flexibility in what this can look like. The goal here is to demonstrate that you’ve experienced real Regulatory tasks, enjoyed the work, and want to do more of it. It also shows that you’re capable of taking initiative.

If you focus on these three areas in your resume – and push through the uncertainty along the way – you’ll give yourself a strong chance of landing your first role in Regulatory.



Author Bio
Angela Coy is a RAC-certified Regulatory Affairs professional, currently serving as Associate Director, Regulatory CMC at Replimune. A PhD scientist by training, she is passionate about mentoring aspiring and early-career Regulatory professionals. Angela lives in Western Pennsylvania with her husband, two sons (5 & 2 years old) and beagle.

A weekly roundup of the digital apps and platforms that don’t..well..suck.

🥤Function Health x Erewhon dropped "The World's Healthiest Smoothie"? The year-long collab is a direct callout to wellness marketing BS: health isn't universal, so why does "healthy" food pretend it is? The smoothie was formulated using real biomarker data from Function's members, and each bottle comes with a QR code for $25 off a Function membership. This move is so very aggressively LA, it’s kind of brilliant.

💊  FDA Drug Approval Has Shifted They just killed the 60-year-old "two pivotal trial" rule: one well-designed trial is now the default for drug approvals. Commissioners Makary and Prasad made it official in the NEJM, arguing modern science makes duplicating trials redundant and that cutting development costs could (theoretically) lower drug prices. Sounds great on paper, but for researchers and clinicians who have watched accelerated approvals go sideways before, the question isn't whether one trial can be enough - it is whether it will be.

⚡Kim K launches her own energy drink, but do we really need another celebrity-backed beverage? Her collaboration with company UPDATE is built around paraxanthine, the metabolite your body naturally produces from caffeine. The brand claims it delivers focus without the jitters or crash, and honestly, that's not entirely false: paraxanthine does show a cleaner receptor profile than caffeine in early research. Whether it lives up to the hype is another story. The drink hits 4,000 Walmart stores March 1.

Coming up: careers to consider when pivoting to clinical research, tips from YOU on what really matters when applying to RA (educational background, experience, certifications) and more tea on research, health, wellness and tech.

I live in Louisville, KY.

Lately, I have been meeting so many cool people in the research, tech, and health innovation space, both locally and around the country. Thank baby Jesus for technology, seriously.

What I’ve come to realize is: AI is a huge distraction.

Almost everyone in the tech space wants to build the latest AI-powered platform - the next algorithm, or the next app that disrupts an industry. I mean, that’s all fine and dandy.

But, where are the communities that exist outside of screens? Where are the solutions that make us more human, not less?

We're automating therapy. Automating diagnoses. Automating connection. Meanwhile, we're lonelier, sicker, and more burned out than ever. Here's a radical idea: maybe the future of health innovation isn't another chatbot.

Go outside and take a damn walk. Have dinner with your friends & family. Protect the irreplaceable value of a real human professional.

We need to re-learn how to be human again.

Welcome home. See you in the next issue. 🖤

p.s. send me an email and let me know where you’re reading from!