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
Biopharmaceuticals / Rare Diseases / Regulatory Affairs
Required skills
Strategic leadership, cross-functional collaboration, regulatory landscape analysis, patient experience data synthesis, stakeholder management, vendor partnership management, change management, influence on senior leaders, global matrix team execution, AI/emerging technology adoption.
Preferred skills
Advanced degree (MPH, MBA, MPA, PhD, MD), regulatory authority engagement, rare disease experience, multi-country regulatory knowledge, additional languages.
Technologies
Artificial intelligence, patient-reported outcome measures (PROMs), patient preference studies tools.
Responsibilities
Lead cross-functional strategy to integrate PED into regulatory submissions; translate regulatory trends into data generation strategies; provide strategic leadership for patient participation in regulatory meetings; lead strategic vendor partnerships; drive transformation of data-use practices.
Seniority
Director, strategic leadership & global matrix execution