RGO x Unitec Venture Talks #10

Regulatory Affairs with Suzanne Einmahl

What

For young healthtech and biotech founders, getting familiar with regulatory and medical affairs early makes a big difference.

This session will walk through the key things to know and simple first steps to take — so you can plan ahead, avoid surprises later, and set your project on the right track from day one.

Who

Entrepreneurs or anyone with a startup idea.

When

November 10, 2025 - 12:15-13:30

Where

Sciences II
Room A50B

Further Information

Suzanne Einmahl, Pharm.D., Ph.D. is an independent consultant with over 20 years of experience in regulatory affairs, with a focus on EMA and FDA submissions and strategic interactions with regulatory agencies. Her expertise spans multiple therapeutic areas, including oncology, rare diseases, and advanced therapies such as cell and gene therapies.

She has led over 70 regulatory projects, supporting companies from early-stage biotech spin-offs to top-tier pharmaceutical firms. Suzanne earned her Ph.D. in Pharmaceutical Sciences from the University of Geneva and has a strong track record in regulatory strategy, clinical development planning, and authoring key regulatory documents throughout the product lifecycle.

2025