Strategic Director, Managed Access & Patient Access

Mass Digital Health; Boston (MA); On-site; USD 140,000 - 391,000; Full time

Job summary

IQVIA is seeking a Director, Managed Access Regulatory Strategy to help build a regulatory strategy offering supporting patient access programs for investigational therapies outside traditional clinical settings.

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

Qualifications

• 10+ years of regulatory affairs or regulatory strategy experience.
• Experience with Expanded Access Programs, Post-Trial Access, Open Label Extension studies, compassionate use, or similar access pathways.
• Strong understanding of global regulatory requirements governing access to investigational therapies.
• Experience advising on product labeling strategy and import/export considerations.
• Demonstrated ability to engage clients, uncover needs, shape solutions, 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, and commercial stakeholders is preferred.
• Prior experience within a managed access provider, CRO, pharmaceutical company, biotechnology company, or regulatory consulting organization is highly relevant.
• Equivalent applied experience may be considered.

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 strategy

Client engagement

Proposal development

Cross-functional collaboration

Business development

Regulatory affairs

Education

Bachelor's degree

Advanced degree

Job description

IQVIA is seeking a Director, Managed Access Regulatory Strategy to help build a regulatory strategy offering supporting patient access programs for investigational therapies outside traditional clinical settings.

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