Director, Global Managed Access & Regulatory Strategy

IQVIA; Durham (NC); Hybrid; USD 140,000 - 391,000; Full time

Job summary

IQVIA is seeking a Director, Managed Access Regulatory Strategy to lead regulatory strategy offerings supporting patient access programs for investigational therapies outside traditional trials. This role will drive Expanded Access Programs, Post-Trial Access, Open Label Extension studies, compassionate use, and named patient access initiatives.

You will advise sponsors on global pathways, country-specific labeling, and import/export considerations, while partnering with account and delivery

Qualifications

• 10+ years of regulatory affairs or strategy experience in pharma/biotech
• Experience supporting expanded access, post-trial access, or similar programs
• Strong understanding of global regulatory pathways for access to investigational therapies
• Experience advising on product labeling, regulatory requirements by country, and import/export
• Proven ability to engage clients, shape solutions, and support proposals
• Experience in client-facing consulting, business development, or sales discussions
• Experience working with regulatory, clinical, supply, real world evidence, pharmacovigilance, commercial and medical teams

Responsibilities

• Support regulatory strategy for Expanded Access Programs, Post-Trial Access, Open Label Extension and compassionate use.
• Advise sponsors on global pathways for access to investigational therapies.
• Provide guidance on country-specific labeling, regulatory requirements and import/export considerations.
• Serve as a credible SME in client discussions, proposals and bid defense.
• Partner with account, regulatory, real world, clinical and operational teams to identify and price new opportunities.
• Help refine IQVIA's regulatory services for managed access and patient access programs.
• Contribute to methodologies, templates, pricing approaches, proposal language, and delivery models.
• Work across IQVIA teams to align regulatory strategy with market demand and client expectations.
• Provide senior regulatory input across active client engagements and escalation discussions.
• Support delivery teams in navigating regulatory and operational questions without broad people management duties.

Skills

Regulatory strategy

Managed access

Client-facing

Proposal development

Global regulatory compliance

Cross-functional collaboration

Pharma/biotech industry experience

Education

Bachelor's degree in life sciences or related

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

Job description

IQVIA is seeking a Director, Managed Access Regulatory Strategy to lead regulatory strategy offerings supporting patient access programs for investigational therapies outside traditional trials. This role will drive Expanded Access Programs, Post-Trial Access, Open Label Extension studies, compassionate use, and named patient access initiatives.

You will advise sponsors on global pathways, country-specific labeling, and import/export considerations, while partnering with account and delivery