Regulatory Affairs Director (Expanded Access Programs)

myTomorrows

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 with Microsoft 365 tools (e.g., Word, Excel, Teams, SharePoint) What we offer: * Impactful work that helps patients gain access to potentially lifesaving treatments. * International work environment, scale-up energy and flat organizational structure which encourages creativity and accountability. * Competitive salary, annual performance bonus and an Employee Stock Option Plan. * Great career development opportunities in a fast-growing company. * Learning and development budget alongside internal knowledge sharing sessions. * Hybrid working model if you're in the Netherlands. * Policies to support working parents. * Healthy lunch at the thriving Amsterdam office. * Unlimited access to professional guidance by certified psychologists via OpenUp * Enjoy monthly events hosted by our vibrant Culture Club as well as an annual ‘myTomorrowland’ company-wide celebration! 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.

myTomorrows

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 As a Product Marketing Manager at myTomorrows, you will define how our products are positioned, understood, adopted, and embedded into real-world clinical and research workflows across the global healthcare ecosystem. Your focus is on product positioning, adoption, and real-world clarity, translating complex product capabilities into clear, real-world value for key stakeholders You will sit at the intersection of Product, Commercial, and Medical, bringing customer and user insight into how our solutions are positioned, communicated, and adopted by key stakeholders. What you'll do in this role * Own the Product Narrative: Shape and refine the end-to-end narrative across clinical trials and Expanded Access, clearly differentiating myTomorrows from legacy databases and lead-gen platforms. * Drive Adoption: Translate physician workflows and trial site needs into scalable messaging frameworks that remove friction and increase user engagement. * Bridge the Gap: Act as the voice of the market; synthesize insights from sites, physicians, and sponsors to feed actionable requirements back into the Product team. * Enable Teams: Build product-native enablement assets (narratives, workflow diagrams, value frameworks) to empower Commercial, Medical, and Growth teams. * Lead Product Launches: Own product readiness for new features and launches, ensuring internal alignment on messaging and use-case clarity. What you bring to the table * Must-Have Requirement: Deep, proven experience within the BioPharma, Clinical Trials, or Expanded Access (EAP) ecosystem. Understanding the complex regulatory, operational, and protocol-driven constraints of this industry is essential for this role. * Experience: 4–6 years in Product Marketing or Product Strategy within HealthTech, digital health, or biopharma. * Storytelling & Structure: Exceptional structured thinking with the ability to map complex product capabilities to real-world user outcomes. * Execution: Relentless ownership and follow-through—you take accountability for outcomes, not just outputs. * Cross-Functional Agility: Comfortable navigating 0-to-1 environments and collaborating closely with Product, Commercial, and Medical stakeholders. * User Empathy: Deep understanding of the distinct workflows and pain points of trial sites, rare disease ecosystems, and pharma teams. What success looks like in 6 months * One Unified Story: A clear, jargon-free product narrative that the Commercial and Medical teams can pitch confidently in under 60 seconds. * Data-Driven Impact: Improved referral-to-enrollment conversion driven by clearer workflow communication and localized messaging. * Feedback Loop: An established, fast-paced insight loop between users and the product team, replacing internal assumptions with real-world clinical realities. What we offer * Impactful work that helps patients gain access to potentially lifesaving treatments. * International work environment, scale-up energy, and a flat organizational structure encouraging creativity and accountability. * Competitive salary, annual performance bonus, and an Employee Stock Option Plan. * Great career development opportunities in a fast-growing company. * Learning and development budget alongside internal knowledge sharing sessions. * Attractive pension plan, full premium covered by myTomorrows. * Hybrid working model. * Policies to support working parents. * Healthy lunch at the thriving Amsterdam office. * Unlimited access to professional guidance by certified psychologists via OpenUp. * Enjoy monthly events hosted by our vibrant Culture Club as well as an annual 'myTomorrowland' company-wide celebration! 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.

myTomorrows

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: APPLIED AI ENGINEER As Applied AI Engineer at myTomorrows, you will help us become more AI-native in how we work, build, and deliver value to patients, physicians, trial sites and (bio-)pharma partners. Your primary focus is internal: the teams, workflows, and operational processes inside myTomorrows. This is not a pure research role, and it is not a “prompt engineer” role. You are an experienced software engineer who knows how to build reliable systems, and who is experienced with the possibilities created by LLMs, agents, AI-assisted coding, retrieval, workflow automation, and internal tooling. You will work as part of our AI Acceleration initiative: a small, high-leverage team focused on safely applying AI across the organization. You embed with internal teams, e.g. Operations, Regulatory, Commercial, Marketing, to find the highest-leverage points of intervention, build production-ready solutions, and leave behind systems that teams can own and operate without you. A key part of the role is not just building things yourself, but helping myTomorrows learn how to build with AI. You will help define reusable patterns, guardrails, evaluation approaches, and engineering practices so that AI-assisted work becomes reliable, secure, maintainable, and scalable. Given that most of our team is located in the Netherlands, we only consider candidates for this position who live within commuting distance of our office in Amsterdam. HOW YOU WORK Each engagement follows the model of a “Forward Deployed Engineer”: Insertion. When you start a mission, you sit with the people who do the actual work: not the people who manage them. You watch, you ask questions, and you map what's really happening: the tools, the manual steps, the tribal knowledge, the workarounds that nobody questions anymore. Your first deliverable is not code. It is a situational awareness map. Discovery. From that map, you identify the highest-leverage intervention point: not the most technically interesting problem, but the one that, if solved, would make the most visible difference to the most people in the shortest time. Delivery. You build production-capable solutions on real data with measurable success criteria defined upfront. You identify an internal champion in week one who will own the system after you leave, and you embed them in the work from the start. Handoff. You leave behind a running system, not a prototype. You leave behind an eval framework and runbook so the system doesn't rot. And you leave behind an AI substrate — connectors, pipelines, and workflow patterns — that makes the next mission faster. WHAT YOU’LL DO IN THIS ROLE * Build production-capable AI-enabled internal tools, workflow automations, agents, and integrations that solve real business problems by embedding with internal teams. * Use modern LLM capabilities such as structured outputs, tool calling, retrieval-augmented generation, agentic workflows, prompt/context engineering and creating evals. * Help teams translate ambiguous business problems into clear, testable, AI-assisted delivery plans. * Build backend services, APIs, integrations, and internal applications using modern software engineering practices. * Work closely with Product, Engineering, QA, DevOps, Data, Legal, Privacy, and Security to ensure AI-built software is safe, secure, observable, and maintainable. * Design and implement evaluation approaches for AI systems, including test sets, human review loops, quality criteria, failure mode analysis, and monitoring. * Create reusable playbooks, templates, prompts, Skills, MCPs and examples that help other teams adopt AI effectively. * Help assess whether a solution should remain a lightweight internal tool, be transferred to a business owner, be hardened by Product & Engineering, or be stopped. * Stay up to date with the rapidly evolving AI engineering landscape and translate relevant developments into practical opportunities for myTomorrows. WHAT YOU BRING TO THE TABLE * 3+ years of professional software engineering experience, ideally in a product, platform, backend, fullstack, startup, or scale-up environment. * Strong software engineering fundamentals. You have built and maintained real systems before (and before vibe-coding was thing), and you know that shipping reliable software is about more than generating code. * Experience with backend development, ideally with Python and modern API development. * Experience with relational databases such as MySQL, PostgreSQL, or Oracle. * Experience with cloud platforms such as AWS, Azure, or GCP. * Strong understanding of testing, code review, observability, security, documentation, and maintainability. * Hands-on experience with the modern essentials of AI agents, agentic engineering and AI coding tools: LLM APIs, agents, RAG, MCPs, Skills, workflow automation and AI-enabled product development. * Ability to work independently in ambiguous environments, while communicating clearly with technical and non-technical stakeholders. * Strong product sense: you care about solving the actual problem, not just using the newest tool. * A pragmatic startup mentality: you can move fast, make sensible trade-offs, and know when to prototype, when to harden, and when to stop. * Excellent English communication skills. NICE TO HAVE * Experience with FastAPI, Pydantic, SQLAlchemy, uv, ruff, pre-commit, GitHub Actions, or similar tools. * Experience with AWS-native architectures, infrastructure as code, Terraform, serverless, Kubernetes, or cloud-native platform work. * Experience with frontend development, especially Angular, React, TypeScript, or fullstack personal projects. * Experience building internal tools, developer tools, workflow automation, or operations tooling. * Experience with AI evaluation frameworks, model monitoring, prompt/version management, or human-in-the-loop review systems. * Experience with healthcare, pharma, clinical research, regulated environments, privacy-sensitive data, or compliance-heavy workflows. * Experience with tools such as Claude Code, Codex, Cursor, GitHub Copilot, LangChain/LangGraph, LlamaIndex, n8n, or similar AI/workflow platforms. WHAT SUCCESS IN THE FIRST 6 MONTHS LOOKS LIKE * You have built trust with Product, Engineering, DevOps, Data, and business stakeholders by delivering useful AI-enabled solutions without creating unmanaged technical debt. * You have delivered 2-3 high-impact AI Acceleration missions, such as an internal tool, workflow automation, agentic engineering improvement, or AI-assisted product delivery pilot. * You have shipped production-capable software with clear ownership, tests, documentation, observability, and security considerations. * You have created reusable templates, prompts, scripts, or examples that other teams can use. * You have helped teams understand where AI is genuinely useful, where it is not ready yet, and what guardrails are needed. * You have contributed to a culture where AI-assisted engineering is judged by objective production outcomes: correctness, security, maintainability, observability, and business value. CURRENT TECH STACK We are fully cloud-native, leveraging AWS and adopting a lean, API-first product development approach driven by modern cloud technologies and thoughtful design practices. Our current Backend Engineer posting describes a stack including Python, FastAPI, Pydantic, SQLAlchemy, MySQL/PostgreSQL, Angular, GitHub Actions, Renovate, ruff, uv, pre-commit, Docker, Docker Compose, Kubernetes, Terraform, DynamoDB, and Neo4j. As Applied AI Engineer focused on internal use cases, you will often work in lighter-weight stacks like scripts, Skills, MCPs, APIs, workflow tools, internal dashboards rather than full product infrastructure. Familiarity with the product stack is useful context, but your day-to-day tooling will be shaped by the mission. WHAT WE OFFER * Impactful work that helps patients gain access to potentially lifesaving treatments. * A unique opportunity to help define how a HealthTech scale-up becomes AI-native. * International work environment, scale-up energy, and a flat organizational structure that encourages creativity and accountability. * Competitive salary, annual performance bonus, and an Employee Stock Option Plan. * Great career development opportunities in a fast-growing company. * Learning and development budget alongside internal knowledge-sharing sessions. * Attractive pension plan, full premium covered by myTomorrows. * Hybrid working model. * Policies to support working parents. * Healthy lunch at the thriving Amsterdam office. * Unlimited access to professional guidance by certified psychologists via OpenUp. * Monthly events hosted by our vibrant Culture Club as well as an annual myTomorrowland company-wide celebration. 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.