Sr. Manager/Associate Director, Regulatory Affairs

Oruka Therapeutics • Waltham, MA

67d • $161,000 - $208,000 • Hybrid

About The Position

Oruka Therapeutics is developing novel biologics for chronic skin diseases, aiming to provide patients with significant relief and high rates of disease clearance. The company is seeking passionate individuals to join its core team and contribute to establishing an engaged, inclusive, and positive company culture. This role will support regulatory activities for development programs, contribute to global regulatory plans, provide regulatory guidance, support health authority interactions, and ensure the timely preparation and submission of regulatory applications. The ideal candidate will be a collaborative partner with strong strategic thinking and operational execution skills in a fast-paced biotechnology environment.

Requirements

• Bachelor’s degree in a life sciences discipline required
• 8 - 10 years of progressive Regulatory Affairs experience in biotechnology or pharmaceutical development
• Experience supporting regulatory activities for drugs and/or biologics in clinical development, including health authority interactions and global submissions
• Experience authoring and/or coordinating regulatory submissions and agency briefing documents
• Strong understanding of global regulatory requirements, including US/EU regulations, ICH guidelines, and ex-US development considerations for drugs and biologics
• Ability to interpret regulatory guidance and apply it in a practical, risk-based manner
• Excellent communication, collaboration, organizational, and project management skills
• Strong scientific and analytical thinking with the ability to connect regulatory requirements to development objectives
• Ability to manage multiple priorities and work effectively in a dynamic environment

Nice To Haves

• Advanced degree (MS, PharmD, PhD, or equivalent) preferred
• RAC certification is a plus
• Experience in dermatology, immunology, inflammation, or related therapeutic areas is advantageous

Responsibilities

• 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.
• 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.
• 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.
• 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.
• Build strong partnerships across functional teams through effective communication and collaboration.
• Provide regulatory input and risk-based recommendations to support cross-functional decision-making.

Benefits

• Competitive salary and benefits package
• Eligibility for matching 401(k) and participation in ESPP
• Comprehensive health, dental, vision, and life insurance
• Flexible working arrangements
• A collaborative, mission-driven culture
• The opportunity to play a meaningful role in advancing a differentiated biologics portfolio with the potential to redefine treatment expectations for patients with chronic skin diseases

What This Job Offers

• Job Type: Full-time
• Career Level: Senior