Regulatory Affairs Director (Expanded Access Programs)

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.