Regulatory Affairs Director

myTomorrows B.V.

Job Overview

Location

Canada

Job Type

Full-time

Full Job Description

📋 Description

• Lead the translation of global regulatory strategy into actionable plans across Expanded Access Programs (EAPs), clinical trials, and Real-World Data initiatives.
• Oversee multiple concurrent regulatory programs, ensuring timely, high-quality delivery aligned with client expectations and internal quality standards.
• Identify, assess, and proactively manage cross-program risks, dependencies, and resource constraints to maintain operational continuity.
• Direct, coach, and develop a team of Regulatory Affairs Managers and senior professionals, setting clear performance expectations and fostering accountability.
• Drive the standardization, scalability, and efficiency of regulatory processes across global operations and service lines.
• Serve as the senior point of contact for clients on all regulatory matters, including participation in client discussions, audits, and interactions with Health Authorities.
• Embed regulatory expertise into end-to-end program delivery by collaborating closely with Program Management, Medical Affairs, Quality Assurance, and Supply Chain teams.
• Ensure full compliance with global regulatory requirements and internal processes, supporting inspection readiness and audit preparedness across all regions.
• Implement data-driven improvements to enhance regulatory workflow, reduce time-to-access, and increase operational reliability.
• Maintain up-to-date knowledge of evolving regulatory frameworks in EAPs, clinical trials, and real-world evidence environments.
• Champion a culture of compliance, quality, and continuous improvement within the Regulatory Affairs function.
• Represent myTomorrows in external regulatory engagements and act as a trusted advisor to BioPharma partners and healthcare stakeholders.
• Support the scaling of Regulatory Affairs capabilities globally in alignment with the company’s expansion into 134 countries and growing client base.
• Ensure all regulatory activities align with the company’s mission to accelerate patient access to therapies in development.

🎯 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
• Participation in a rapidly scaling organization backed by a €25M investment from Avego Healthcare Capital
• Collaborative, mission-driven culture focused on accelerating patient access to therapies
• Work alongside multidisciplinary teams including Medical Affairs, Quality Assurance, and Supply Chain

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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