Sr. Manager/Associate Director, Regulatory AffairsMenlo Park, California, United States; Remote; Waltham, Massachusetts, United StatesOruka Therapeutics 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.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.Position SummaryThe 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 ResponsibilitiesRegulatory Development SupportServe as a regulatory representative on multidisciplinary program teams for one or more investigational productsContribute to the development and execution of global regulatory plans aligned with program objectives and development timelinesSupport regulatory planning across the product lifecycle, from early clinical development through registration planning and lifecycle managementEvaluate regulatory precedent, guidance, and competitive intelligence to inform regulatory recommendations and development planningPartner closely with cross functional development team and program leadership to support development objectives and regulatory requirementsSupport regulatory assessments related to development pathways, expedited programs, pediatric requirements, and regional filing considerationsHealth Authority InteractionsSupport the planning, preparation, and execution of health authority interactions, including FDA meetings, scientific advice procedures, and other agency engagementsContribute to the development of briefing documents, meeting requests, responses to regulatory questions, and other regulatory communicationsParticipate in interactions with health authorities and support follow-up activities and action plansHelp translate regulatory feedback into clear recommendations for cross-functional teamsSubmissions and Regulatory ExecutionIndependently manage assigned regulatory submission activities, including preparation and coordination of INDs/CTAs and amendments, annual reports, investigator brochure updates, briefing packages, and other regulatory documentsContribute to major regulatory submissions and health authority deliverables for assigned development programsCoordinate submission planning, timelines, content development, and review activitiesPartner with Regulatory Operations and external vendors to support dossier planning, publishing, and electronic submissionsEnsure regulatory documents are scientifically accurate, compliant, and aligned with development objectivesRegulatory ComplianceMonitor and interpret global regulatory requirements, guidance documents, and policy developments relevant to assigned programsSupport compliance with applicable regulations, ICH guidelines, and company proceduresContribute to the development and continuous improvement of regulatory processes, templates, and SOPsAssist with tracking and fulfillment of regulatory commitmentsLeadership and CollaborationBuild strong partnerships across functional teams through effective communication and collaborationProvide regulatory input and risk-based recommendations to support cross-functional decision-makingQualificationsEducationBachelor's degree in a life sciences discipline requiredAdvanced degree (MS, PharmD, PhD, or equivalent) preferredRAC certification is a plusExperience8 - 10 years of progressive Regulatory Affairs experience in biotechnology or pharmaceutical developmentExperience supporting regulatory activities for drugs and/or biologics in clinical development, including health authority interactions and global submissionsExperience authoring and/or coordinating regulatory submissions and agency briefing documentsExperience in dermatology, immunology, inflammation, or related therapeutic areas is advantageousSkillsStrong understanding of global regulatory requirements, including US/EU regulations, ICH guidelines, and ex-US development considerations for drugs and biologicsAbility to interpret regulatory guidance and apply it in a practical, risk-based mannerExcellent communication, collaboration, organizational, and project management skillsStrong scientific and analytical thinking with the ability to connect regulatory requirements to development objectivesAbility to manage multiple priorities and work effectively in a dynamic environmentWillingness to travel up to 20%CompensationAn appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.The anticipated salary range for the Senior Manager level is $161,000 - $187,000 and the Associate Director level is $182,000 - $208,000.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.What We OfferCompetitive salary and benefits packageEligibility for matching 401(k) and participation in ESPPComprehensive health, dental, vision, and life insuranceFlexible working arrangementsA collaborative, mission-driven cultureThe 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