Active Searches in
Pharma & Biotech

The ideal candidate has led regulatory strategy for an NDA or BLA through approval, has direct experience managing FDA Type A and B meetings, and has operated in a mid size or emerging company environment where they were the most senior regulatory voice. Large pharma regulatory operations leadership alone will not be sufficient for this role.

This is a retained search. Shortlist will be presented in early Q2 2025. To be considered, please submit your profile below and reference VP Regulatory in the role field.

We are targeting candidates with direct rare disease or specialty payer experience, established relationships with major PBMs and specialty pharmacy channels, and demonstrated ability to build access strategy from the ground up. This company has a lean team and the right person will need to be both a strategist and a doer.

This is a medically credentialed role. The company will not consider non physicians for this position. The Director will have direct input into the Phase III design and will interface with FDA as a clinical spokesperson. Equity package is meaningful and the company anticipates a Series D financing in late 2025.

Candidates must have a terminal degree (MD, PharmD, or PhD) and prior leadership of a field medical team of at least six. Hematology experience is required. Oncology background will be considered if accompanied by strong hematology KOL relationships.

Prior experience building a QA function in a cell and gene therapy or biologics environment is strongly preferred. The ideal candidate has led a team through a PAI or pre approval inspection and understands how to scale quality systems rapidly without sacrificing compliance. This is a builder role in the truest sense.

This company needs a builder. Someone who has stood up a TA function before in a pharmaceutical or biotechnology environment, knows how to hire fast without sacrificing quality, and is comfortable being the most senior TA leader in the organization. Prior experience as the sole TA leader at a company scaling through commercialization is ideal.