Director, Global Managed Access Regulatory Strategy

IQVIA; Philadelphia (Philadelphia County); On-site; USD 235,000 - 391,000; Full time

Job summary

IQVIA is seeking a Director, Managed Access Regulatory Strategy to lead regulatory services for patient access programs outside traditional trials. You will shape global pathways, labeling considerations, and cross-border access strategies while engaging with sponsors and delivering practical, market-ready solutions.

The role emphasizes building a new capability, supporting business development, and providing credible regulatory guidance to clients across Expanded Access, Post-Trial, Open Label

Qualifications

• 10+ years of regulatory affairs or regulatory strategy with managed access experience.
• Experience supporting expanded/post-trial access, compassionate use, or similar pathways.
• Strong understanding of global regulatory requirements for access to investigational therapies.

Responsibilities

• Support regulatory strategy for Expanded Access Programs, Post-Trial Access, Open Label Extension, compassionate use and named patient access.
• Advise sponsors on global pathways and labeling considerations for access to investigational therapies.
• Collaborate with cross-functional teams to identify, shape, and price new client opportunities.
• Provide senior regulatory input in proposals, bids, and client discussions.
• Help refine IQVIA’s regulatory offerings supporting managed access and patient access programs.

Skills

Regulatory strategy

Managed access

Expanded access

Client-facing

Business development

Education

Bachelor’s degree in life sciences or related

Advanced degree (MS/ MPH/ PharmD/ PhD/ JD/ MBA)

Job description

IQVIA is seeking a Director, Managed Access Regulatory Strategy to lead regulatory services for patient access programs outside traditional trials. You will shape global pathways, labeling considerations, and cross-border access strategies while engaging with sponsors and delivering practical, market-ready solutions.

The role emphasizes building a new capability, supporting business development, and providing credible regulatory guidance to clients across Expanded Access, Post-Trial, Open Label