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Regulatory Affairs Director – Expanded Access Programs
myTomorrowsRegulatory Affairs Director managing global regulatory strategy execution for myTomorrows. Responsible for leading a team and ensuring regulatory compliance across multiple programs and regions.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Equal Opportunity Employer
- Commitment to diversity and inclusion