Director, Regulatory Affairs Strategy

Oruka Therapeutics

Global Regulatory Lead at Oruka Therapeutics developing regulatory strategies for biologics in immunology and dermatology. Leading key health authority interactions and major submissions for clinical programs.

Posted 4/15/2026full-timeMenlo Park • California, Massachusetts • 🇺🇸 United StatesSenior💰 $213,000 - $286,000 per yearWebsite

About the role

Key responsibilities & impact

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.
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 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.

Requirements

What you’ll need

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

Benefits

Comp & perks

Competitive salary and benefits package.
A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
Opportunities for professional growth and development.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategyregulatory submissionsINDsCTAsbriefing packagesclinical developmentprogram leadershipregulatory leadershiprisk assessmentglobal guidance

Soft Skills

leadershipcommunicationcollaborationstrategic thinkingproblem-solvinginterpersonal skillsorganizational skillsadaptabilitydecision-makingproject management

Certifications

Bachelor's degreeadvanced degreeRAC