Associate Director/Director, Regulatory Operations
Faeth Therapeutics is a clinical-stage oncology company listed on Nasdaq that recently raised $200M in funding. With a strong scientific foundation and a founding team that includes the discoverer of our target pathway, we are advancing PIKTOR, a multi-node PI3K/AKT/mTOR inhibitor program, toward multiple near-term milestones. We are a small, focused team where every person has direct impact — united by a shared commitment to care deeply, create boldly, and never stop learning.
We are seeking an Associate Director, Regulatory Operations to own the operational backbone of our global regulatory filings. This is a hands-on, high-ownership role responsible for the planning, and manage publishing, and delivery of submissions to FDA and ex-US health authorities with CROs,, for the administration and data integrity of our Regulatory Information Management System (RIMS), for our submission archive and inspection readiness posture
The role is deliberately scoped to grow. As our pipeline advances within the clinical development stages ultimately towards registration, the person in this seat will have the opportunity to move beyond execution into submission strategy, regulatory intelligence, and functional leadership — shaping how the regulatory organization operates rather than only running it.
Reports to: VP, Regulatory Affairs
Location: Remote (U.S.)
Responsibilities:
