Director, Managed Access Regulatory Strategy

Boston, United States of America | Full time | Home-based | R1563921 Overview IQVIA is seeking a Director, Managed Access Regulatory Strategy to help build a regulatory strategy offering supporting patient access programs for investigational therapies outside of traditional clinical trial settings. This role will support Expanded Access Programs, Post-Trial Access, Open Label Extension studies, compassionate use programs, named patient programs, global labeling considerations, and import/export regulatory requirements.

The Director will serve as a senior client-facing regulatory strategist, helping pharmaceutical and biotechnology sponsors understand their options, shape fit-for-purpose solutions, and move forward with confidence. The role requires someone who can translate client needs into compelling proposals, partner with account and delivery teams to sell the solution, and bring practical regulatory insight into early opportunity discussions.

The successful candidate will bring experience in managed access, expanded access, post-trial access, compassionate use, open label extension, or related regulatory strategy work. They should be energized by the opportunity to help grow a new capability, engage directly with clients, support business development, and contribute to practical solutions that improve patient access to investigational therapies.

Responsibilities

Support regulatory strategy for Expanded Access Programs, Post-Trial Access, Open Label Extension studies, compassionate use, and named patient access initiatives. Advise sponsors on global pathways supporting access to investigational therapies. Provide guidance on country-specific requirements, product labeling, import/export considerations, and cross-border access needs. Serve as a credible subject matter expert in client discussions, proposals, and bid defense activities. Partner with account, regulatory, real world, clinical, and operational teams