Director, Patient Experience & Regulatory Engagement
Core
Strategic bridge between Global Medical Affairs, R&D, Marketing, and the patient community to integrate patient experience data (PED) into regulatory submissions and therapeutic development.
Role type
Director, Patient Experience & Regulatory Engagement
Builds
Patient-informed risk/benefit narratives and regulatory strategies for rare disease therapeutics
Domain
Biotech/Pharmaceutical, Rare Disease, Regulatory Affairs
Required skills
Strategic leadership, cross-functional team management, regulatory landscape analysis, patient experience data synthesis, stakeholder influence, vendor partnership management, change management, AI/emerging technology adoption
Preferred skills
Data science or management degree, Regulatory/Clinical Development/Consulting experience, patient-focused drug development knowledge
Technologies
Artificial intelligence, emerging technologies
Responsibilities
Lead cross-functional strategy to integrate PED into regulatory submissions; Translate regulatory shifts into PED generation strategies; Provide strategic leadership to generate PED and shape risk/benefit narratives; Lead strategic vendor partnerships for high-quality outputs
Seniority
Director, strategic leadership & matrix organization influence