Regulatory Affairs Director – Expanded Access Programs

🔥 3 minutes ago

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myTomorrows

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2012

💼 Consulting

📦 Logistics

🏥 Healthcare

💰 Venture Round on 2017-01

Consulting • Logistics • Healthcare

myTomorrows is a healthcare company dedicated to helping patients discover and access experimental treatments through clinical trials and expanded access programs. They provide personalized patient navigation and support to empower patients and their families in making informed decisions regarding their treatment journeys. By leveraging technology and partnerships with healthcare professionals and biopharmaceutical companies, myTomorrows aims to bridge the gap between patients and innovative therapies currently in development.

📋 Description

• 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 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, coach, and develop Regulatory Affairs Managers and senior team members • Partner closely with Program Management, Medical Affairs, Quality Assurance, and Supply Chain • Drive standardization, consistency, and scalability of regulatory processes • Act as a senior point of contact for clients on regulatory matters

🎯 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

• Equal Opportunity Employer • Commitment to diversity and inclusion