Client background
This small, clinical-stage startup is developing multiple products to treat rare skin diseases. Their lead program is currently in Phase 3 trials and the company plans to file their first NDA in early 2026. Up until now they had relied solely on consultants for their regulatory filings.
Challenge
With critical milestones approaching, the company needed to bring Regulatory in-house. They were looking for a senior Regulatory Affairs leader who could:
- Establish and build the entire Regulatory function
- Lead global strategy and agency interactions (U.S., EU, UK)
- Oversee and execute their first NDA submission
- Led marketing applications
- Thrive as the sole Regulatory expert in a small, fully virtual startup
Strong Rare Disease expertise and prior NDA leadership were must-haves—making this a highly specialized and high-stakes search.
Approach
Dennis Partners conducted an Engaged Search for this crucial role. We recruited and vetted senior Regulatory professionals on the East Coast who fit the client’s qualifications. We focused on Directors and Senior Directors with strong Rare Disease experience along with NDA filings. We prioritized those candidates who had been the sole Regulatory person at smaller companies, and who would be comfortable at a very small startup. Within a few weeks of starting the search, we submitted several candidates who met these criteria.
Result
The client quickly moved through phone and video interviews, ultimately inviting their top candidate for an in-person meeting to confirm alignment. Once they were ready to move forward, Dennis Partners managed the offer negotiation and secured a successful acceptance. The candidate—an accomplished Regulatory leader with Rare Disease and NDA experience—has officially started in the role. The client was thrilled with the outcome and is now well-positioned for their next phase of growth.