Global Leader, Managed Access Regulatory Strategy

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

Job summary

IQVIA seeks a Director of Managed Access Regulatory Strategy to build and lead regulatory offerings for patient access programs outside traditional trials. You will guide complex access strategies (EAP/PTA/OLE), advise on global labeling and import/export, and collaborate with cross-functional teams to shape solutions for sponsors and patients.

You will influence proposals, lead strategic discussions with clients, and help deliver practical, market-relevant regulatory consulting.

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.
• Proven ability to engage clients, 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.

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 ensure regulatory strategy is aligned with market demand, 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.

Education

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

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

Job description

IQVIA seeks a Director of Managed Access Regulatory Strategy to build and lead regulatory offerings for patient access programs outside traditional trials. You will guide complex access strategies (EAP/PTA/OLE), advise on global labeling and import/export, and collaborate with cross-functional teams to shape solutions for sponsors and patients.

You will influence proposals, lead strategic discussions with clients, and help deliver practical, market-relevant regulatory consulting.