Director, Regulatory Affairs Strategy
Oruka Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Menlo Park • California • Massachusetts • United States
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Salary
💰 $213,000 - $286,000 per year
Job Level
About the role
- 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
- 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
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
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