In today’s episode of Regulatory Voices, I speak with Nataskia Lampe, a regulatory affairs leader with more than 20 years of experience across pharma, biotech, global regulatory strategy, Reg CMC, operations and asset strategy.
This is a really open conversation about what a non-linear career in Regulatory Affairs can look like, and how each unexpected step can add something valuable over time.
What I found really interesting about Nataskia’s journey is that she did not set out on a traditional regulatory path.
She started in the lab, stepped into a laboratory compliance role that no one else wanted, moved through graduate school, Department of Defense clinical trial work, IRB compliance, consulting alongside former FDA reviewers, smaller companies, big pharma, asset strategy, and eventually back into biotech leadership.
We also discuss the idea of “cross-pollinating” in Regulatory.
Nataskia shares what it is like to move across CMC, clinical, legal, quality and asset strategy while still keeping the regulatory lens at the centre. In smaller companies especially, regulatory professionals often have to go deeper into areas outside their core function, not because it is neatly written into a job description, but because the business needs it.
Finally, we explore the difference between health authority interactions at large pharma companies and small biotechs.
She also shares a very grounded perspective on how the room changes, how decision making changes, how preparation changes, and why credibility, judgment and knowing when to bring in the right expertise matter so much.
One line from Nataskia really stayed with me and we can all take with us:
“Everything you have ever wanted is on the other side of fear”
Brought to you by Codon Partners, Life Science Staffing
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