Director, Global Managed Access Regulatory Strategy

IQVIA; New York (NY); On-site; USD 140,000 - 391,000; Full time

Job summary

IQVIA seeks a Director of Managed Access Regulatory Strategy to build a regulatory strategy offering that supports patient access programs for investigational therapies outside traditional clinical trial settings.

The role includes Expanded Access Programs, Post-Trial Access, Open Label Extension studies, compassionate use, and named patient programs, with global labeling considerations and import/export regulatory requirements.

Qualifications

• 10+ years of experience in regulatory affairs, regulatory strategy, managed access, patient access, clinical development, or related pharmaceutical services setting.
• Experience supporting Expanded Access Programs, Post-Trial Access, Open Label Extension studies, compassionate use programs, named patient programs, or similar access pathways.
• Strong understanding of global regulatory requirements governing access to investigational therapies.
• Experience advising on product labeling strategy, country-specific regulatory requirements, and import/export considerations.
• Demonstrated ability to engage clients, uncover needs, shape solutions, support proposal development, and communicate complex regulatory issues clearly.
• Experience in client-facing consulting, business development, proposal support, solution shaping, pricing, or sales discussions is highly preferred.
• Experience working across regulatory, clinical operations, supply, real world evidence, pharmacovigilance, commercial, and medical stakeholders is preferred.
• Prior experience within a managed access provider, CRO, pharmaceutical company, biotechnology company, or regulatory consulting organization is highly relevant.

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 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.

Skills

Regulatory affairs

Regulatory strategy

Managed access

Patient access

Clinical development

Business development

Education

Bachelor's degree in life sciences, pharmacy, public health, regulatory affairs, or related field

Advanced degree (MS, MPH, PharmD, PhD, JD, or MBA)

Job description

IQVIA seeks a Director of Managed Access Regulatory Strategy to build a regulatory strategy offering that supports patient access programs for investigational therapies outside traditional clinical trial settings.

The role includes Expanded Access Programs, Post-Trial Access, Open Label Extension studies, compassionate use, and named patient programs, with global labeling considerations and import/export regulatory requirements.