Regulatory Affairs Manager (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 & Pharmacovigilance Manager As the Regulatory Affairs and Pharmacovigilance Manager, you will be responsible for ensuring compliance of our processes with country-specific expanded access regulations globally. In this role, you'll be a key contributor to our regulatory and quality infrastructure, keeping us aligned with global legislation. You will be actively working together with Medical Affairs, Program Management, Quality Assurance, and Supply Chain and will report to the Director of Regulatory Affairs and Pharmacovigilance (Emily says hi). What you will do in this role: - Support the development and execution of regulatory strategies for Expanded Access Programs (EAPs) involving biologicals, cell therapies, and synthetic drugs. - Act as the Regulatory Affairs and Pharmacovigilance expert for communications with clients (pharmaceutical companies) and submissions to Health Authorities, as well as cross-functional meetings and audits. - Prepare, compile, and submit regulatory dossiers for cohort and named patient Expanded Access Programs (EAPs) on behalf of clients. - Provide input and support for the regulatory strategy for setting up and executing EAPs (e.g., where, when, and how). - Collaborate with the Commercial team to support new EAPs. - Ensure timely and compliant handling of all regulatory and pharmacovigilance activities related to EAPs. - Stay up to date on relevant global laws, regulations, and guidelines impacting EAPs. - Assist in drafting, reviewing, and maintaining regulatory documentation and templates. - Liaise with the Pharmacovigilance service provider to ensure alignment and compliance. - Contribute to maintaining department documentation such as SOPs (Standard Operating Procedures), QIs (Quality Incidents), and CAPAs (Corrective and Preventive Actions). What you bring to the table: - 5+ years of relevant experience in Regulatory Affairs, including experience in Expanded Access. - Working knowledge of fundamental principles of Pharmacovigilance is required. - Solid understanding of national and international legislation and regulation relating to Expanded Access - A Bachelor’s or Master's degree in Life Sciences or a related field - Experience working directly with clients or external stakeholders in a professional setting - Strong communication skills (written and verbal) in English; able to convey complex topics clearly to both internal teams and external parties. Knowledge of additional languages is a plus - Comfortable collaborating across teams and working in a cross-functional environment - Proactive problem solver with the ability to identify potential regulatory or operational challenges early and suggest practical solutions - Familiarity w