Regulatory Affairs Senior Consultant

Client background

This small, clinical stage biotechnology company is developing biologic therapeutics for the treatment of severe autoimmune and inflammatory diseases.  With two programs in Phase 1 in the US and plans for clinical trials abroad, the company needed some additional regulatory support.


The CMO was urgently seeking a Regulatory Affairs Consultant who could provide strategic regulatory direction for the company’s pre-clinical and clinical-stage programs and lead an upcoming IND. They wanted to quickly find a seasoned consultant who could immediately execute regulatory activities for a first-in-human trial and interact directly with FDA.


Due to the client’s high level of urgency, Dennis Partners quickly wrote a job description and immediately started searching for available consultants.  Within three days from our initial conversation with the client, we presented six available regulatory consultants who met the client’s criteria.


The client interviewed their top three candidates by phone and reached a decision in a few days. Dennis Partners was able to get all the necessary paperwork in place swiftly so that the consultant was able to start working immediately.   The consultant began working for the client exactly two weeks from our initial discussion with the CMO.  She has made a substantial impact on the organization and has “exceeded all expectations so far.”