Regulatory Affairs Director (Expanded Access Programs)

The Opportunity:

Regulatory Affairs Director

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
• 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