Job Description
About Us: Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. Job Title: Director / Senior Director, Regulatory Affairs Strategy Location: Preferred: Hybrid (Menlo Park, CA or Waltham, MA). Remote will be considered. Position Summary The Director / Senior Director, Regulatory Affairs Strategy will serve as the Global Regulatory Lead for one or more development programs and will report to the Vice President, Regulatory Affairs. This individual will define and execute regulatory strategies that support rapid, high-quality global development of Oruka’s biologics portfolio, with an emphasis on differentiated programs in immunology and dermatology. This is a highly visible, cross-functional leadership role for a regulatory strategist who can translate an ambitious product profile into actionable development and registration plans. The successful candidate will lead health authority interactions, shape key development milestones, guide major submissions, and proactively identify regulatory risks and opportunities to support corporate objectives. At Oruka, this role offers the opportunity to help shape regulatory strategy for potentially best-in-class antibodies intended to redefine treatment expectations in psoriasis and related diseases, including programs with the potential for very infrequent dosing, deep efficacy, and durable responses. Key Responsibilities Regulatory Strategy and Leadership Serve as Global Regulatory Lead on multidisciplinary program teams for one or more investigational products Develop, drive, and continuously refine global regulatory strategies aligned with program goals, development timelines, and corporate priorities Provide regulatory leadership across the product lifecycle, from early development through registration planning and lifecycle management Assess regulatory precedent, competitor actions, and evolving global guidance to identify strategic risks, opportunities, and options Partner closely with Clinical, Clinical Operations, Nonclinical, CMC, Quality, Medical, Biometrics, and Program Leadership to ensure regulatory strategy is integrated into overall development planning Lead regulatory scenario planning for key inflection points, including dose selection, indication strategy, expedited development opportunities, pediatric requirements, and regional filing considerations Health Authority Interactions Lead the preparation, strategy, and execution of key health authority interactions, including FDA and ex-U.S. agency meetings, scientific advice, and other formal engagements Serve as primary regulatory contact for assigned programs and represent Oruka externally with health authorities, consultants, and partners, as applicable Lead the development of briefing documents, meeting requests, responses to regulatory questions, and other agency-facing communications Translate agency feedback into clear strategic recommendations and cross-functional action plans Submissions and Execution Lead or oversee preparation of high-quality global regulatory submissions, including INDs/CTAs and amendments, annual reports, investigator brochure updates, briefing packages, and components of future marketing applications, as applicable Ensure submission plans, timelines, content strategies, and review processes support efficient execution Partner with Regulatory Operations and external vendors to support dossier planning, publishing, and e-submissions Ensure regulatory documentation is scientifically sound, compliant, and aligned with the target product profile and overall development strategy Compliance and Regulatory Excellence Monitor and interpret relevant global regulations, guidance, and policy developments, and communicate implications to cross-functional teams Support regulatory inspection readiness and compliance with applicable regulations, ICH guidelines, and comp