Sr. Manager/Associate Director, Regulatory Affairs

About the role

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: Sr. Manager/Associate Director, Regulatory Affairs Location : Preferred: Hybrid 3 days/week in office (Menlo Park, CA or Waltham, MA). Remote will be considered. Position Summary The Senior Manager / Associate Director, Regulatory Affairs will support regulatory activities for one or more development programs and contribute to the development and execution of global regulatory plans that support the advancement of Oruka's biologics portfolio. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications. The successful candidate will be a collaborative partner who can balance strategic thinking with strong operational execution in a fast-paced biotechnology environment.

Responsibilities

• Regulatory Development Support
• Serve as a regulatory representative on multidisciplinary program teams for one or more investigational products
• Contribute to the development and execution of global regulatory plans aligned with program objectives and development timelines
• Support regulatory planning across the product lifecycle, from early clinical development through registration planning and lifecycle management
• Evaluate regulatory precedent, guidance, and competitive intelligence to inform regulatory recommendations and development planning
• Partner closely with cross functional development team and program leadership to support development objectives and regulatory requirements
• Support regulatory assessments related to development pathways, expedited programs, pediatric requirements, and regional filing considerations
• Health Authority Interactions
• Support the planning, preparation, and execution of health authority interactions, including FDA meetings, scientific advice procedures, and other agency engagements
• Contribute to the development of briefing documents, meeting requests, responses to regulatory questions, and other regulatory communications
• Participate in interactions with health authorities and support follow-up activities and action plans
• Help translate regulatory feedback into clear recommendations for cross-functional teams
• Submissions and Regulatory Execution
• Independently manage assigned regulatory submission activities, including preparation and coordination of INDs/CTAs and amendments, annual reports, investigator brochure updates, briefing packages, and other regulatory documents
• Contribute to major regulatory submissions and health authority deliverables for assigned development programs
• Coordinate submission planning, timelines, content development, and review activities
• Partner with Regulatory Operations and external vendors to support dossier planning, publishing, and electronic submissions
• Ensure regulatory documents are scientifically accurate, compliant, and aligned with development objectives
• Regulatory Compliance
• Monitor and interpret global regulatory requirements, guidance documents, and policy developments relevant to assigned programs
• Support compliance with applicable regulations, ICH guidelines, and company procedures
• Contribute to the development and continuous improvement of regulatory processes, templates, and SOPs
• Assist with tracking and fulfillment of regulatory commitments
• Leadership and Collaboration
• Build strong partnerships across functional teams through effective communication and collaboration
• Provide regulatory input and risk-based recommendations to support cross-functional decision-making

Requirements

• Education
• Bachelor's degree in a life sciences discipline required
• Advanced degree (MS, PharmD, PhD, or equivalent) preferred
• RAC certification is a plus
• 8 - 10 years of progressive Regulatory Affairs experience in biotechnology or pharmaceutical development
• Experience supporting regulatory activities for drugs and/or biologics in clin

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