Regulatory Affairs Director

myTomorrows B.V.

Job Overview

Location

Amsterdam HQ

Job Type

Full-time

Full Job Description

📋 Description

• Lead the translation of global regulatory strategy into actionable plans for Expanded Access Programs (EAPs), clinical trials, and Real-World Data initiatives across multiple regions and service lines.
• Oversee a portfolio of concurrent regulatory programs, ensuring timely, high-quality delivery aligned with client expectations and internal quality standards.
• Proactively identify, assess, and mitigate cross-program risks, dependencies, and resource constraints to maintain program continuity and compliance.
• Directly lead, coach, and develop a team of Regulatory Affairs Managers and senior professionals, setting clear performance expectations and fostering accountability.
• Drive standardization, scalability, and operational excellence across regulatory processes by identifying inefficiencies and implementing data-driven improvements.
• Serve as the senior point of contact for clients on all regulatory matters, including participation in client discussions, audits, and interactions with Health Authorities.
• Collaborate closely with cross-functional teams including Program Management, Medical Affairs, Quality Assurance, and Supply Chain to embed regulatory requirements into end-to-end program delivery.
• Ensure full adherence to global regulatory frameworks and internal compliance processes, supporting inspection readiness and audit preparedness across all operational areas.
• Act as a strategic advisor to internal stakeholders on regulatory implications of new programs, geographic expansions, and evolving regulatory landscapes.
• Maintain up-to-date knowledge of international regulatory requirements for EAPs, clinical trials, and real-world evidence collection in over 134 countries.
• Contribute to the development and refinement of regulatory workflows, templates, and tools to enhance consistency and efficiency across global operations.
• Represent myTomorrows in regulatory engagements with BioPharma partners, patient advocacy groups, and healthcare institutions to strengthen trust and alignment.
• Ensure all regulatory activities support the company’s mission of accelerating patient access to emerging therapies while maintaining the highest ethical and compliance standards.

🎯 Requirements

• 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

🏖️ Benefits

• Opportunity to work with a global health tech company supporting over 17,000 patients and 60+ BioPharma clients
• Join a mission-driven organization with a €25M investment to scale global impact
• Work in a diverse, inclusive environment that celebrates difference and supports team member well-being
• Collaborate with cross-functional teams across 134 countries to drive meaningful patient access

Skills & Technologies

Onsite

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myTomorrows B.V.

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About myTomorrows B.V.

myTomorrows B.V. operates an Amsterdam-based platform that connects physicians and patients worldwide with pre-approval and off-label medicines. The company identifies investigational or licensed drugs not yet commercially available in a patient’s country, navigates regulatory pathways, arranges supply, and supports pharmacovigilance. It serves oncology, neurology, and rare diseases, working with pharmaceutical companies, hospitals, and regulators in Europe, North America, and Asia-Pacific.

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