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Hey Fellow Misfit PharmDs! 👋

“I took three years off to travel Europe between FDA drug approvals,” Dr. Matt Lee mentioned casually during our chat.
Excuse me, what?
This was definitely not the conversation I expected when I asked him to explain what Regulatory Affairs meant…

And yet here I was, interviewing Dr. Matt Lee, who turned his PharmD into TWO successful NDAs (that’s New Drug Applications), took a 3-year sabbatical to explore Europe, and now works remotely with compensation packages that would make most retail pharmacists drop their counting trays.

What I learned made me realize how many of us are missing out on this incredible career path simply because we don’t know it exists. So let’s break this down like we’re explaining it to someone who’s never heard of Regulatory Affairs (which, honestly, was exactly what I needed).

Oh, and he started as a K-mart pharmacist. Not with some super-secret inside track. So, he really started from zero.

What Even IS Regulatory Affairs? 🤔

Think of drug development like a complex football game. You’ve got different players (clinical trials, manufacturing, safety teams) all trying to score a touchdown (get a drug approved). Regulatory Affairs professionals? They’re the quarterbacks.

As Dr. Lee puts it: “Regulatory Affairs is the quarterback that manages the process for the company and is the liaison with regulatory authorities like the FDA, EMA, Health Canada, etc.”

In plain English, they:

• Champion drugs from early development through approval
• Figure out the best path to get medicines approved
• Manage all the documentation (they’re literally “the library” for the company)
• Talk to the FDA and other regulatory bodies
• Write important documents and safety reports

But here’s what made me sit up straight: Dr. Lee says it’s no more stressful than retail pharmacy - just way more rewarding.

The Day-to-Day Life: Not Your Typical Pharmacy Gig 💼

“To quote Billy Joel, it’s a lot of filling out forms and standing in lines,” Dr. Lee jokes. But don’t let that fool you. A typical day might include:

• Meetings with clinical development teams
• Writing safety reports
• Submitting documents to the FDA
• Managing timelines for drug approvals
• Responding to questions from regulatory agencies

The best part? Many roles are now remote.

The Reality Check: Work-Life Balance 🌴

Unlike retail pharmacy, where taking a day off requires months of advance notice and complex scheduling gymnastics, Regulatory Affairs offers surprising flexibility. As Dr. Lee puts it: “When I have a doctor’s appointment, I just go to my doctor’s appointment and come back. I just don’t schedule any meetings.”

The stress level? “I would say no more stressful than working retail pharmacy,” Dr. Lee shares. “Just like working as a retail pharmacist, some days you have 20 things you need to get done today. There are other days that are much more laid back. I definitely don’t find it any more stressful than working in retail pharmacy, but I find it much more rewarding.”

Dr. Lee’s Wild Ride: From Kmart to FDA Strategist 🎢

Here’s where it gets interesting. Dr. Lee’s career path reads like a “choose your own adventure” book:

• Started as a Kmart pharmacist
• Moved to NABP (took a 50% pay cut!)
• Became VP of a staffing company at 29
• Transitioned to Regulatory Affairs
• Got 2 NDAs approved
• Took 3 years off to travel Europe
• Short stint at Home Depot (yes, really!)
• Started his own remodeling company
• Returned to Regulatory Affairs

His secret? “I’ve never said no when an interesting opportunity comes along.”

The most eye-opening part? That 50% pay cut he took early in his career led to opportunities that eventually earned him compensation packages with bonuses bigger than most pharmacists’ annual salaries. (We’re talking $50K bonuses, folks!)

Breaking Into Regulatory Affairs: It’s Easier Than You Think 🚀

“You don’t have to have your license to be in Regulatory Affairs,” Dr. Lee emphasizes. “Your PharmD is enough to get started.”

Entry-Level Positions to Target:

• Senior Manager, Regulatory Affairs
• Medical Information roles (“It’s literally right in your sweet spot if you’re working in retail pharmacy or clinical pharmacy”)
• Medical Science Liaison positions
• Regulatory Operations roles (“If you’re very techy, this is for you”)
• Advertising & Promotion teams (perfect for business-minded PharmDs)

Dr. Lee’s insider tip: “Nobody teaches you Regulatory Affairs. There aren’t schools graduating Regulatory Affairs professionals. You can pretty much do it with any degree, but the industry looks very highly towards people with PharmDs.”

The Money Talk 💰

• Starting salary: $150K-175K
• 20-30% target bonus (“I went from being happy with a $1,500 pharmacy manager bonus to many multiples of that”)
• Full healthcare coverage (often at 100% for you and your family!)
• Remote work possibilities
• Generous time off (most companies shut down for 2 weeks at Christmas!)
• Stock options/grants in many companies
• Cell phone and internet stipends (often untaxed!)

Dr. Lee’s perspective: “When I came to understand what their compensation packages were and the amount of time they had off during the year, I was like, ‘Whoa, what was I doing being a retail pharmacist?’”

The Dr. Lee Method of Breaking In 🎯

1. Start with Training:
   • Take courses from the Regulatory Affairs Professionals Society (RAPS)
   • Get project management certification
   • Look for free online courses (especially in California!)
2. Build Your Personal Brand:
   • Be mindful of your social media presence
   • Create a strong LinkedIn profile
   • Share your knowledge and experiences
3. Network Differently:
   • Reach out to regulatory professionals on LinkedIn
   • Be honest about what you don’t know
   • Focus on building genuine connections
4. Leverage Your PharmD Skills:
   • Understanding complex processes
   • Breaking down complicated information
   • Knowledge of insurance and prior authorizations
   • Understanding of pharmacy law and regulations

The Most Important Thing? Just Start 🌟

Dr. Lee’s parting wisdom? “Just keep going, keep yourself moving forward. Don’t wait for that perfect opportunity.”

Start small:

• ​Take one RAPS course​
• Connect with 3 regulatory professionals on LinkedIn
• Update your LinkedIn profile to highlight transferable skills
• Look into project management certifications

Remember: “Just because you don’t have 100% of qualifications doesn’t mean you shouldn’t apply for the job. If there’s nothing new for you and nothing to learn, then really what’s there besides the paycheck?”

Your Next Chapter: Choose Your Own Adventure 🌈

While Regulatory Affairs is an incredible path (with equally incredible compensation!), it’s just one of many exciting directions your PharmD can take you. Before you start sending LinkedIn connection requests to every regulatory professional you can find, take a moment to reflect:

• Does the idea of being the quarterback for drug development light you up?
• Are you energized by the thought of managing complex documentation and liaising with regulatory bodies?
• Would you thrive in a role that combines strategic thinking with technical expertise?

Remember: The best career move isn’t always the one with the highest salary or the most impressive title – it’s the one that aligns with your strengths and interests. Maybe Regulatory Affairs isn’t your jam, and that’s perfectly okay! Your PharmD is a master key that can unlock doors in:

• Medical Affairs
• Health Tech
• Pharmaceutical Industry
• Healthcare Consulting
• Medical Writing
• And so much more…

Want to explore ALL your options before committing and making your next move? Join the waitlist for PharmD HQ’s flagship course, where we deep dive into these career paths and help you find your perfect fit with your unique aptitudes and competencies.

*This article was based on my interview with Dr. Lee for informational purposes only. Our aim was to teach about an industry most PharmDs don’t know about, and not to represent any specific company.

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With grit and gratitude,
​Jamie

P.S. Big thanks to Dr. Matt Lee for pulling back the curtain on this fascinating career path. Follow him on LinkedIn for more insights into the regulatory affairs world! 🙌

P.P.S. Next week, we’re diving into another hidden PharmD career path. Reply to this email with roles you’d like me to investigate!

Here are the links to his favorite resources:

1. ​Calbright College Project Management Certificate (FREE for CA residents)
2. ​RAPS Course Catalogue​
3. ​Google Project Management (with a nod to AI)
4. ​MIT certificate AI in Pharma & Biotech​

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Final PS- 🚀 My flagship PharmD HQ cohort 1 closed earlier this month with 50 PharmDs loving the content and giving in 5/5 stars. If you are bummed you missed it an eager to get in on the next launch, register your interest here. PharmD HQ is your springboard to understand all the non-trad opportunities out there plus what is the best one for you. See you on the inside! 👋🏻

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