About the job
About Oruka Therapeutics
Oruka Therapeutics (Nasdaq: ORKA) develops biologics for chronic skin conditions, with a focus on achieving strong disease clearance through infrequent dosing, sometimes as little as once or twice per year. The company’s pipeline includes antibodies engineered by Paragon Therapeutics that target the underlying mechanisms of plaque psoriasis and other dermatological and inflammatory diseases. Learn more at www.orukatx.com.
Role Overview
Title: Director / Senior Director, Regulatory Affairs Strategy
Location: Hybrid preferred (Menlo Park, CA or Waltham, MA). Remote considered.
This position serves as Global Regulatory Lead for one or more development programs and reports directly to the Vice President of Regulatory Affairs. The Director/Senior Director will define and execute regulatory strategies to support the global advancement of Oruka’s biologics, with a focus on immunology and dermatology programs.
What You Will Do
- Lead regulatory strategy for assigned programs, translating product goals into actionable development and registration plans.
- Drive key regulatory milestones and oversee major submissions.
- Represent Oruka in interactions with health authorities.
- Identify regulatory risks and opportunities in alignment with company objectives.
- Collaborate across functions to ensure high-quality, timely global development of the portfolio.
What Sets This Role Apart
This is a visible leadership role with influence over the regulatory direction of programs aiming for infrequent dosing, strong efficacy, and lasting results in psoriasis and related conditions. The position offers the chance to shape strategies for a pipeline of engineered antibodies intended to change how chronic skin diseases are treated.
