Role Description This role offers the opportunity to contribute to the development of innovative precision oncology therapies by supporting regulatory strategy, health authority interactions, and regulatory submissions in Japan. The Regulatory Affairs Manager, Japan will support assigned development programs and products, working closely with cross-functional teams and global regulatory colleagues to ensure successful execution of regulatory activities. Key Responsibilities - Regulatory Strategy & Execution - Support the development and execution of regulatory strategies for assigned programs and products in Japan. - Assess regulatory requirements and provide recommendations to support development and registration activities. - Monitor changes in the regulatory environment and communicate potential impact to project teams. - Health Authority Interactions & Regulatory Submissions - Support the preparation and execution of PMDA consultations and regulatory interactions. - Contribute to the preparation of briefing packages, regulatory responses, and submission documents. - Support NDA/J-NDA submissions and post-approval regulatory activities. - Cross-Functional Collaboration - Partner with Clinical Development, Clinical Operations, Medical Affairs, Safety, CMC, Quality, and other functions to support regulatory objectives. - Participate in global project teams and contribute Japanese regulatory perspectives. - Vendor & CRO Management - Coordinate activities performed by regulatory consultants, vendors, and CRO partners. - Monitor timelines, deliverables, and quality of outsourced activities. Qualifications - Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related discipline. - Typically 5+ years of pharmaceutical or biotechnology industry experience, including Regulatory Affairs experience. - Familiarity with Japanese pharmaceutical regulations and drug development processes. - Experience supporting regulatory submissions and health authority interactions. - Strong communication and organizational skills. Preferred Skills - Oncology drug development experience. - Experience supporting PMDA consultations. - Experience with NDA/J-NDA submissions. - Experience working on global development programs.

• Develop and sustain long-term customer relationships • Engage customers at all levels • Operationalizes customer servicing requirements • Understand customer-specific nuances • Plans, executes, problem solves, and monitors initiatives • Identifies best practices to drive growth/improve customer experience • Develops customer-specific documentation to support account management • Ensure customers are aware of changes to offerings • Develop, lead, and drive operational solutions to customers • Communicate effectively with senior-level management • Provides back-up coverage to support team members • Must be willing to travel as required

• Own the broker and consultant distribution sales strategy, with accountability for revenue targets across non-owned channels • Transition the sales organization from a reactive account management model to a proactive hunter/farmer structure • Recruit, onboard, and scale new broker and FMO relationships to expand Pivot's active distribution footprint • Drive new business development with independent agents, general agents, and field marketing organizations (FMOs) • Represent Pivot Health at industry events, carrier partner meetings, and key broker/consultant forums • Lead and develop the Account Management team, ensuring existing broker relationships are nurtured, productive, and growing • Establish SLAs, performance metrics, and accountability frameworks for the AM team • Partner with internal operations and member services to resolve broker escalations and improve the end-to-end broker experience • Develop and execute a tiered broker engagement model (key account vs. general book) • Hire, coach, and develop a team of BDMs and Account Managers; establish clear roles, comp structures, and performance expectations • Create a winning team culture grounded in accountability, collaboration, and results • Work cross-functionally with marketing, operations, and product to align distribution strategy with company priorities • Contribute to the company's Growth Roadmap and quarterly operating plan (Rocks) as a key member of the leadership team • Provide regular pipeline, forecast, and performance reporting to the President • Identify market trends, competitive dynamics, and channel opportunities to inform product and pricing decisions

• Build and execute a tiered enablement strategy across partner types (agencies, tech/ecosystem, resellers) -- balancing scalable one-to-many programs with high-touch support for priority partners. • Design structured onboarding and certification programs (live and async) that equip partners to position Fundraise Up by use case, run discovery and qualification, co-sell with internal Sales, and support post-sale handoffs. • Own the partner webinar and workshop calendar -- covering network enablement, product updates, co-sell plays, and public-facing events that drive pipeline with partner participation. • Build and maintain a full enablement library: playbooks, talk tracks, battlecards, objection handling, and implementation guides. • Manage enablement distribution through the PRM, portal, and/or LMS, coordinating with Product Marketing to keep partner messaging current and consistent. • Work hands-on with Salesforce, PartnerStack, Crossbeam, and Partner Fleet to support enablement delivery, tool adoption, and co-sell workflows. • Triage and qualify inbound enablement requests before escalation to Partner Managers. • Define and track KPIs tied to business outcomes: time to first referral, partner activation rate, partner-sourced pipeline, win rate lift, and enablement satisfaction. • Run a quarterly operating cadence covering program roadmap, performance review, and iteration planning.