Regulatory Affairs Director (Expanded Access Programs)

Regulatory Affairs Director (Expanded Access Programs) LocationAmsterdam HQEmployment TypeFull timeLocation TypeHybridDepartmentOperationsAbout myTomorrows myTomorrows is a global health tech company dedicated to breaking down barriers for patients seeking treatment options.   We strive to enable earlier and better treatment access by bridging the gap between those searching for possible options, and the companies who develop them. We work closely with patients, healthcare professionals, trial sites, patient advocacy groups, and BioPharma – connecting key stakeholders in the drug development ecosystem.   We’ve developed a cutting-edge AI-powered technology platform that simplifies and streamlines access to drugs in development. To support our users and clients, we have a range of industry-expert specialized teams ready to help. Our services include clinical trial patient recruitment, Expanded Access Program management and Real-World Data collection.   With a global footprint spanning 134 countries, to date we’ve supported over 17,000 patients, 3,000 physicians and 350 sites, earning the trust of 60+ BioPharma companies. In October 2025, we closed a €25M investment with Avego Healthcare Capital to fuel our global ambitions and scale the business.  Join us in shaping the future of treatment access - making tomorrow’s therapies accessible for people who need them today. The Opportunity: Regulatory Affairs DirectorAs Regulatory Affairs Director, you will play a critical leadership role in translating our global regulatory strategy into execution across programs, regions, and service lines.You will oversee a portfolio of regulatory activities, ensuring high-quality, compliant, and timely delivery while leading and developing a team of Regulatory Affairs professionals. You’ll work closely with cross-functional teams and act as a senior point of contact for both internal stakeholders and external partners.This role sits at the intersection of strategy, delivery, and leadership, and is key to scaling our Regulatory Affairs capabilities globally.What you'll do in this role:Drive regulatory strategy executionTranslate company and RA/PV strategy into clear regulatory plans across programs and regionsDrive implementation across Expanded Access Programs (EAPs), Clinical Trials, and Real-World Data initiativesOversee program and portfolio deliveryOversee multiple regulatory programs simultaneously, ensuring delivery against timelines, quality standards, and client expectationsIdentify and proactively manage cross-program risks, dependencies, and resource constraintsLead and develop the teamLead, coach, and develop Regulatory Affairs Managers and senior team membersSet clear expectations and drive accountability for performance, quality, and deliveryCollaborate cross-functionallyPartner closely with Program Management, Medical Affairs, Quality Assurance, and Supply ChainEnsure regulatory input is embedded into end-to-end program deliveryDrive operational excellence and performanceDrive standardization, consistency, and scalability of regulatory processesIdentify improvement opportunities and implement data-driven solutionsEngage with clients and stakeholdersAct as a senior point of contact for clients on regulatory mattersSupport client discussions, audits, and regulatory interactions with Health AuthoritiesEnsure quality, compliance, and risk managementEnsure adherence to global regulatory requirements and internal processesSupport inspection readiness and audit preparednessWhat you bring to the table:Advanced degree in life sciences, pharmacy, or a related fieldSignificant experience in Regulatory Affairs within pharma, biotech, or CRO environmentsProven experience managing multiple programs and complex regulatory portfoliosStrong knowledge of global regulatory frameworks (EAP, clinical trials, or similar environments)Demonstrated leadership experience managing teams and developing talentExcellent stakeholder management and communication...