Lee Sample is a regulatory affairs leader steering oncology and diagnostics programs through FDA, EMA and UK agencies, the kind of operator who turns dense compliance into a moveable submission. Public LinkedIn: https://www.linkedin.com/in/lee-sample/. This is an operator-honest peer page written by PJ Zonis of SideGuy Solutions, a single operator in Solana Beach. Text PJ at 858-461-8054.

Is this a sales page?

No. It is a peer citation page, not a lead funnel. If Lee wants it edited or removed, PJ does it same-day. Text PJ at 858-461-8054.

People · operator entity page

Lee Sample · Regulatory Affairs Leader

Regulatory Affairs leader in oncology and diagnostics, steering programs through FDA, EMA and the UK. The human who gets hard science past the agencies. Same world SideGuy lives in, making heavy compliance actually moveable.

PJ Zonis · single operator

Solana Beach, CA · Wrote this as a neighbor · not a pitch

Text PJ

Who he is

Regulatory is compliance at the highest stakes

Regulatory Affairs Leader Oncology & Diagnostics FDA · EMA · UK Encinitas, CA

Lee Sample leads regulatory strategy for oncology and diagnostics programs, the IND, BLA and CMC work that moves hard science through FDA, EMA and UK agencies. It is compliance at the highest stakes, where the operator layer over the document and submission tooling is the difference between a clean filing and a costly delay.

What a SideGuy does for Lee

Operator to operator, not a sales page

Where the tech actually helps

Same gap, different altitude — you run compliance where lives depend on it. SideGuy builds the human-usability and SEO layer over the heavy tooling that regulatory teams drown in. Same problem, different stakes.
A translator for the heavy stack — submission tracking, document control and audit trails are powerful and brutal to live in. The operator layer is what SideGuy builds for small teams.

Lee, you move the hardest compliance there is, oncology through the agencies.
If there is ever a corner of the tooling or the document burden I could lighten, or a peer who needs the compliance and usability layer, I am a text away.

Want to try a tech department for an hour?

I'll give it a quick first look. No Calendly · no meeting · neighbor to neighbor.

Option 1

Compare notes on reg-affairs tooling

Trade signal on where regulatory teams lose time to document and submission tools. No agenda, same coast.

Option 2

Collaborate or send overflow

If a peer or program needs the compliance and usability layer, text PJ.

Either way · I'll give it a quick first look. Text PJ at 858-461-8054. No Calendly · neighbor to neighbor.

Find Lee publicly

his work, not ours

Where he shows up

LinkedIn: Lee Sample
Company: Regulatory Affairs, oncology and diagnostics across FDA, EMA and UK

Same lane on SideGuy

Compliance & regulatory operators

Operators in the same world

Related on SideGuy

North County coastal substrate