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Hello, I am Jeremy Jakob

Your Strategic Partner for Accelerated Global Market Access​

When your breakthrough therapy is ready to change patients' lives, regulatory complexity shouldn't stand in the way.

I'm Jeremy Jakob, and for 18 years I've transformed challenging CMC regulatory pathways into accelerated market entry opportunities for pharmaceutical and biotech companies worldwide. From cutting-edge biologics to complex vaccines, I've guided 200+ successful submissions across EU, US, Canada, Japan, and global markets, consistently achieving approval timelines that exceed industry benchmarks.

My strategic approach combines deep technical expertise with performance-driven thinking from competitive athletics, turning regulatory requirements from obstacles into competitive advantages.

Whether you're a nimble biotech seeking first approval or an established company expanding globally, I deliver the regulatory mastery that accelerates your innovation to the patients who need it most.

Ready to transform your regulatory challenges into market opportunities?

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My Story

From Martial Artist to Regulatory Strategist: A Journey of Precision, Performance, and Patient Impact

 

It started with a simple question from my judo sensei when I was seventeen:

"I see you fit for teaching, would you be able to give some courses?"

At the time, I thought he was just talking about martial arts. I had no idea this mindset would become the foundation of my entire approach to navigating the complex world of pharmaceutical regulation—where anticipating challenges, thinking strategically and share knowledge can literally mean the difference between life and death for patients waiting for breakthrough therapies.

Growing up in the Alsace region, on the crossroads between France, Germany, and Switzerland, I learned early that borders are just lines on maps—but the differences they represent can create real barriers for people who need help.

This multicultural environment sparked my fascination with how the same scientific innovation could face completely different regulatory pathways just kilometers apart. Why should geography determine whether a patient receives a life-saving treatment? This question would drive my entire career.

The discipline came from the dojo.

Twenty years of competitive judo taught me that excellence isn't about one perfect moment—it's about thousands of small, precise actions executed under intense pressure. Every , training after classes, I learned that preparation beats improvisation, that studying your opponent's patterns reveals opportunities others miss, and that the difference between winning and losing often comes down to split-second decisions made with incomplete information. I didn't know it then, but I was training for regulatory affairs.

The turning point came during my pharmaceutical engineering studies at University Louis Pasteur Strasbourg.

During my internship at Sanofi-Pasteur, I witnessed a team of brilliant scientists whose groundbreaking vaccine research sat stalled in regulatory review for months. The science was sound, the manufacturing was validated, but the regulatory strategy was reactive rather than strategic. Watching these researchers—people who had dedicated their lives to protecting children from preventable diseases—wait while bureaucratic processes slowly ground forward, I realized where I could make the biggest impact.

That's when I understood that regulatory affairs isn't about compliance—it's about translation.

Scientists speak the language of innovation; manufacturers speak the language of precision; patients speak the language of hope. Regulatory authorities speak the language of evidence and risk management. My role isn't just to check boxes—it's to be the bridge that connects these worlds, ensuring that brilliant science reaches the people who need it without compromising the safety and efficacy standards that protect us all.

The real education came in the trenches and from failures

At Novartis, I learned how global pharmaceutical giants orchestrate submissions across dozens of countries simultaneously. At Lonza, I discovered how CDMO partnerships can either accelerate or derail the most promising therapies. At Tillotts, I saw how smaller companies with limited resources can punch above their weight with the right regulatory strategy. Each experience taught me that there's no one-size-fits-all approach—every company, every product, every situation requires a tailored strategy built on deep understanding of both the science and the business.

Regulatory strategy isn't just about business success—it's about human impact.

 I approach every submission like a judo match: with respect for the challenge, meticulous preparation, and the understanding that success comes from turning obstacles into advantages. When the EMA asks for additional manufacturing data, I see an opportunity to showcase our quality systems. When the FDA requests clarification on our clinical endpoints, I see a chance to tell a more compelling story about patient benefit. This isn't naive optimism—it's strategic thinking born from understanding that regulatory reviewers aren't adversaries trying to block innovation; they're professionals trying to ensure that the treatments they approve actually help the patients who receive them.

Today, when I work with biotech founders who've spent years developing life-changing therapies, I see the same passion that drove those Sanofi researchers decades ago.

When I partner with pharmaceutical executives managing global portfolios worth billions, I understand the weight of responsibility they carry. When I collaborate with CDMO partners navigating complex manufacturing requirements, I appreciate the precision required to maintain quality at scale. Each relationship is built on a shared understanding: we're not just moving molecules through regulatory processes—we're opening pathways for human healing.

The statistics tell one story: 200+ successful submissions, approvals across six continents, timelines consistently ahead of industry benchmarks.

But the real story is in the moments you don't see—the late-night strategy sessions ensuring a new treatment  reaches patients in time, the weekend calls coordinating multi-continental submissions so a disease treatment can launch simultaneously in markets where patients are waiting, the careful orchestration of manufacturing scale-up so that breakthrough therapies don't face supply shortages at launch.

This is why I chose to become an independent consultant rather than climb the corporate ladder.

I wanted the freedom to work with the companies and therapies where I could make the biggest difference—whether that's a university spin-out with their first-in-human study or a pharmaceutical giant launching the next blockbuster biologic. Size doesn't matter; impact does. Every successful submission is a victory not just for the company, but for every patient who will benefit from faster access to innovation.

When you work with me, you're not just hiring regulatory expertise—you're partnering with someone who understands that behind every submission is a human story of hope, innovation, and the relentless pursuit of better outcomes for people facing their darkest moments.

This is my calling, my craft, and my commitment to you and the patients your innovations will serve.

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Ready to turn your breakthrough science into life-changing therapy? Let's write that success story together.

Contact

I'm always looking for new and exciting opportunities. Let's connect.

123-456-7890 

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