Regulatory Affairs Director (Expanded Access Programs)

About 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 Director As 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. Geographic Requirement: To ensure seamless collaboration with our teams, applicants must reside within the EST or CST time zones . What you'll do in this role: Drive regulatory strategy execution Translate company and RA/PV strategy into clear regulatory plans across programs and regions Drive implementation across Expanded Access Programs (EAPs), Clinical Trials, and Real-World Data initiatives Oversee program and portfolio delivery Oversee multiple regulatory programs simultaneously, ensuring delivery against timelines, quality standards, and client expectations Identify and proactively manage cross-program risks, dependencies, and resource constraints Lead and develop the team Lead, coach, and develop Regulatory Affairs Managers and senior team members Set clear expectations and drive accountability for performance, quality, and delivery Collaborate cross-functionally Partner closely with Program Management, Medical Affairs, Quality Assurance, and Supply Chain Ensure regulatory input is embedded into end-to-end program delivery Drive operational excellence and performance Drive standardization, consistency, and scalability of regulatory processes Identify improvement opportunities and implement data-driven solutions Engage with clients and stakeholders Act as a senior point of contact for clients on regulatory matters Support client discussions, audits, and regulatory interactions with Health Authorities Ensure quality, compliance, and risk management Ensure adherence to global regulatory requirements and internal processes Support inspection readiness and audit preparedness What you bring to the table: Advanced degree in life sciences, pharmacy, or a related field Significant experience in Regulatory Affairs within pharma, biotech, or CRO environments Proven experience managing multiple programs and complex regulatory portfolios Strong knowledge of global regulatory frameworks (EAP, clinical trials, or similar environments) Demonstrated leadership experience managing teams and developing talent Excellent stakeholder management and communication skills Equal opportunities myTomorrows is an Equal Opportunity Employer and, beyond upholding discrimination-free practices, we are committed to cultivating a workplace where difference and diversity are protected and celebrated. The best work comes from our best selves, and we go to great lengths in supporting our team members to be just that.