Support regulatory activities for one or more development programs and contribute to global regulatory plans.
Work closely with cross-functional teams to provide regulatory guidance throughout product development.
Help ensure timely preparation and submission of high-quality regulatory applications.

Key Responsibilities:

Serve as a regulatory representative on program teams and support health authority interactions.
Manage submission activities including INDs, CTAs, annual reports, and briefing documents.
Monitor global regulatory requirements and support compliance with applicable regulations.

Qualifications:

Bachelor's degree in life sciences required; advanced degree preferred; RAC certification a plus.
8-10 years of progressive Regulatory Affairs experience in biotechnology or pharmaceutical development.
Strong understanding of global regulatory requirements, including US/EU regulations and ICH guidelines.

Compensation and Benefits:

Competitive base salary range $161,000 - $208,000, plus equity and performance-related bonus.
Eligibility for matching 401(k), ESPP, and comprehensive health, dental, vision, and life insurance.
Flexible working arrangements and a collaborative, mission-driven culture.

Oruka Therapeutics

Oruka Therapeutics (Nasdaq: ORKA) develops novel biologics to treat chronic skin diseases like plaque psoriasis, aiming for high rates of complete clearance with dosing as infrequently as once or twice per year. As a small startup building its core team, we seek top talent passionate about making a difference and contributing to an engaged, inclusive, and positive company culture.

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