Sr. Manager/Associate Director, Regulatory Affairs

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.

Key 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 submission