Strategic Director, Managed Access & Patient Regulation

IQVIA; Falls Church (VA); Sur place; USD 140 000 - 391 000; Plein temps

Résumé du poste

IQVIA seeks a Director, Managed Access Regulatory Strategy to help build a regulatory strategy offering supporting patient access programs for investigational therapies outside traditional clinical trials. The role will support Expanded Access Programs, Post-Trial Access, Open Label Extension studies, compassionate use, named patient programs, and global labeling considerations.

The Director will serve as a senior client-facing regulatory strategist, translating client needs into proposals,

Qualifications

• 10+ years of experience in regulatory affairs or regulatory strategy.
• Experience with Expanded Access Programs, Post-Trial Access, Open Label Extension, compassionate use, or named patient access.
• Strong understanding of global regulatory requirements governing access to investigational therapies.
• Bachelor's degree in life sciences, pharmacy, public health, regulatory affairs, health policy, or related field.
• Advanced degree preferred (MS, MPH, PharmD, PhD, JD, or MBA).

Responsabilités

• 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 to identify, shape, price, and sell new client opportunities.
• Help refine IQVIA's regulatory service offerings supporting managed access and patient access programs.
• Contribute to practical methodologies, templates, best practices, pricing approaches, proposal language, and delivery models for EAP, PTA, OLE, labeling, and import/export engagements.
• Work across IQVIA teams to help ensure regulatory strategy is aligned with market demand, operational delivery, and client expectations.
• Provide senior regulatory input across active client engagements, including quality review, escalation support, and strategic issue discussion where needed.
• Help delivery teams navigate complex regulatory and operational questions without broad people-management or full operational leadership responsibility.
• The Director will also contribute to thought leadership and market awareness in managed access regulatory strategy.
• This may include monitoring global regulatory developments, contributing to internal education, supporting conference or publication opportunities, and helping strengthen IQVIA's position as a strategic partner in patient access and managed access regulatory consulting.

Description du poste

IQVIA seeks a Director, Managed Access Regulatory Strategy to help build a regulatory strategy offering supporting patient access programs for investigational therapies outside traditional clinical trials. The role will support Expanded Access Programs, Post-Trial Access, Open Label Extension studies, compassionate use, named patient programs, and global labeling considerations.

The Director will serve as a senior client-facing regulatory strategist, translating client needs into proposals,