Director/Senior Director, Regulatory Affairs Strategy

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 company procedures
• Contribute to the development and continuous improvement of SOPs, templates, and internal regulatory processes
• Track and help ensure fulfillment of regulatory commitments for assigned programs

Leadership

• Influence cross-functional teams through strong strategic thinking, sound judgment, and clear communication in a dynamic biotech environment
• May mentor junior regulatory staff or oversee consultants and external resources supporting assigned programs

Qualifications:

Education

• Bachelor’s degree in a life sciences discipline required; advanced degree preferred; RAC a plus

Experience

• Director: 10+ years of progressive Regulatory Affairs experience in biotechnology or pharmaceuticals
• Senior Director: 12+ years of progressive Regulatory Affairs experience, including broader program leadership and significant health authority interaction
• Strong experience developing and executing global regulatory strategy for drugs and/or biologics in clinical development
• Direct experience authoring and/or leading major regulatory submissions and briefing packages
• Demonstrated experience leading interactions with FDA and international health authorities
• Experience in dermatology, immunology, or inflammation considered advantageous
• Experience in fast-paced biotech settings and comfort operating in a lean, hands-on environment strongly preferred

Skills

• Deep knowledge of global regulatory requirements, including FDA, ICH, and ex-US development considerations
• Strong grasp of development-stage regulatory strategy for biologics
• Ability to interpret evolving regulatory guidance and apply it in a practical, risk-based way
• Excellent leadership, communication, influencing, organizational, and project management skills
• Strong scientific and business judgment, with the ability to connect regulatory strategy to program and company goals
• Ability to manage multiple priorities and thrive in a fast-paced, collaborative environment
• Willingness to travel up to 20%

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for the Director level is $213,000 - $240,000 and for the Senior Director level is $255,000 - $286,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

This role is well suited for a regulatory leader who wants to pair rigorous execution with high-impact strategic thinking at an inflection point for a clinically advancing immunology portfolio.