Associate Director, Regulatory Affairs
Core
Lead regulatory strategy for Global Expanded Access Programs (EAP), Open Label Extension (OLE), and Post-Approval Named Patient Programs (PA-NPP) to expedite safe and effective healthcare product delivery.
Role type
Senior IC regulatory affairs director (global expanded access)
Builds
Global, regional, and multi-country regulatory strategies for EAP, OLE, and PA-NPP
Domain
Clinical research / Regulatory affairs
Deliverable
client delivery
Required skills
Regulatory strategy development, EAP/OLE/PA-NPP program expertise, multi-country regulatory guidance (US/EU/UK/ROW), domestic license maintenance, regulatory authority interaction, team leadership, bid defense capability
Preferred skills
Experience in compassionate use programs, strategic regulatory planning
Technologies
Microsoft Office
Responsibilities
Provide operational oversight for EAP, OLE, and PA-NPP delivery; Maintain US domestic licenses; Oversee global regulatory strategy updates; Interact with regulatory authorities for review approvals; Manage and develop Regulatory Affairs staff; Represent the company in bid defenses and client presentations
