Should we turn this into a series?

Angela Coy, Associate Director of Regulatory Affairs, is back with another gem of an article on sharing how to break into the industry we know and love (or have learned to love):

Last time, I shared the three things that help position your resume for Regulatory roles: hands-on experience, education, and complementary skillsets (i.e., transferable skills).

But in a crowded market, there are a few additional ways to stand out as an entry-level Regulatory professional.

First, show that you understand GxP frameworks. This is especially important if you’re coming from academia, where GxP exposure isn’t common.

Second, don’t be afraid to list published manuscripts. This might be a bit of a hot take. Standard resume advice often says not to include publications when pivoting to a non-research role. But technical writing is a core skill in Regulatory, so this is one resume “rule” that I don’t recommend following.

Third, be specific about your experience. If you have Regulatory or Regulatory-adjacent experience, describe it in a way that shows the role you played. For example, instead of “prepared data for submission in an IND,” try something like “prepared IND-enabling nonclinical packages supporting a first-in-human clinical trial.”

Two other quick wins: list relevant memberships or affiliations (joining RAPS is a great step if you’re serious about Regulatory) and seek referrals whenever possible. Having someone inside the company advocate for you can make a big difference, especially when you’re making a career pivot.

To be clear, these are all nice-to-haves. But the more of them you can check off, the more you demonstrate that you’re serious about building a career in Regulatory.

🤓 In true science-speak, it’s about the totality of the evidence.

When you look at your resume, ask yourself:

Do you look like someone who saw a Regulatory job posting and applied on a whim?

Or like an aspiring Regulatory professional who has intentionally prepared for this career?




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.

🥤David is the viral protein bar everyone's talking about…for the wrong reasons. They are getting sued for two things: allegedly mislabeling calories by 383% above FDA's 20% tolerance limit (lab tests found 268 calories, not the advertised 150), and acquiring Epogee, the only manufacturer of their key ingredient EPG, then allegedly cutting off supply to competitors. FDA limits nutrient misrepresentation to 20%, but if the lawsuit's claims are true, David exceeded this by over 300%and some consumers say it "tastes like powdered dog poo" anyway.

⏳  Biohacker Bryan Johnson walked Paris Fashion Week, which means longevity culture just went from tech bro obsession to mainstream phenomenon - and a wave of unregulated "immortality" products is coming right behind it. The guy spending $2M/year on anti-aging and getting his son's plasma transfusions is now a runway model for "The Immortals," because apparently your epigenetic age is the new Hermès bag.

👶 Parents are spending $249-$349 to mail their babies' poop to startups like Tiny Health and Alba Health, which test the microbiome and recommend "interventions" like specific probiotics or, I'm not making this up, trips to petting zoos to improve gut bacteria diversity. The science says infancy is a critical window for microbiome development, but pediatricians are gently pointing out that the marketing is wildly outpacing the evidence and we have no long-term data proving any of this actually works. Rich parents are literally paying $300 for someone to tell them to visit a farm and calling it "optimizing their child's health."

Some products become cult favorites because they push regulatory boundaries. Here are the ones that made it big despite (or because of) breaking the rules:

🥤AG1 (Athletic Greens) does $300M+ in annual revenue and has never received an FDA warning letter, which isn't luck - it's careful regulatory strategy where the brand walks the line on structure/function claims ("supports immune system") while their army of influencers do the heavy lifting on health claims the brand legally can't make. They built a green powder empire by staying just compliant enough to avoid FDA while letting affiliates operate in the regulatory gray zone, and it's working spectacularly.

💧 Liquid I.V. claims to "hydrate 2-3x faster than water alone" using Cellular Transport Technology, citing a study on a similar formulation, not their exact product, which is regulatory gray area brilliance. It's essentially fancy Pedialyte marketed as innovation: oral rehydration solutions with glucose and sodium are scientifically validated for faster hydration, but whether their specific formula at their specific doses is "2-3x faster" is... let's say debatable.

🤧 Umcka (Cold Care) was a homeopathic cold remedy on shelves for decades claiming to "shorten duration and reduce severity of colds" before FDA finally caught up in 2023 and issued a warning letter - turns out they combined approved homeopathic drugs with Pelargonium sidoides (not listed in the Homeopathic Pharmacopeia), making it an unapproved new drug. The lesson: you can fly under the radar for years, but eventually regulators show up and you're reformulating or recalling.

TLDR: Regulatory failures are perfect for innovation.

Hot take: Theranos failing was the best thing that could have happened to health tech.

Hear me out.

Before Theranos imploded, investors threw money at health tech startups with no clinical validation, no regulatory strategy, and vague promises about "revolutionizing healthcare."

Post-Theranos? Investors actually ask about FDA pathways. They want to see pilot data. They care about regulatory risk.

Theranos didn't kill innovation. It killed bad innovation.

The startups that survived the post-Theranos reckoning are the ones solving real problems with real science. Play Health has clinical protocols. Mecha Health has accuracy benchmarks. LunaBill has measurable ROI.

Meanwhile, AG1 and Liquid I.V. thrive in the CPG world because they learned how to dance on the regulatory edge without falling off.

The companies that win aren't the ones that ignore regulations. They're the ones that understand them well enough to push boundaries without breaking them.

That's the difference between a cult favorite and a cautionary tale.

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Welcome home. See you in the next issue. 🖤

p.s. lots more fun stuff in the issues to come!