Strategic Director, Managed Access & Regulatory Strategy

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

Job summary

IQVIA seeks a Director, Managed Access Regulatory Strategy to design regulatory approaches for Expanded Access, Post-Trial and Open Label Extension programs, ensuring compliant access to investigational therapies.

You will translate client needs into practical proposals, partner with account and delivery teams, and provide senior regulatory input across active engagements while helping build new managed access offerings and thought leadership.

Qualifications

• 10+ years in regulatory affairs or regulatory strategy.
• Experience withExpanded Access Programs, Post-Trial Access or similar pathways.
• Strong client-facing consulting and proposal development skills.
• Experience engaging stakeholders across regulatory, clinical, operations and commercial teams.

Responsibilities

• Support regulatory strategy for Expanded Access Programs, PTA, Open Label Extension and compassionate use initiatives.
• Advise sponsors on global pathways and country-specific requirements for access to investigational therapies.
• Provide guidance on labeling, import/export considerations, and cross-border access needs.
• Serve as a subject matter expert in client discussions, proposals and bid defense activities.
• Collaborate with account, regulatory, clinical, and delivery teams to identify, shape, and price new opportunities.
• Help refine IQVIA's regulatory service offerings for managed access and patient access programs.
• Develop practical methodologies, templates and pricing approaches for EAP, PTA, OLE and related engagements.
• Ensure regulatory strategy aligns with market demand and client expectations across IQVIA teams.
• Provide senior regulatory input across active engagements, including quality review and escalation support.

Skills

Regulatory strategy

Client-facing consulting

Business development

Proposal development

Cross-functional collaboration

Education

Bachelor's degree

Advanced degree preferred

Job description

IQVIA seeks a Director, Managed Access Regulatory Strategy to design regulatory approaches for Expanded Access, Post-Trial and Open Label Extension programs, ensuring compliant access to investigational therapies.

You will translate client needs into practical proposals, partner with account and delivery teams, and provide senior regulatory input across active engagements while helping build new managed access offerings and thought leadership.