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 of traditional clinical trial settings.
The 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.
The Director will serve as a senior client-facing regulatory strategist, helping pharmaceutical and biotechnology sponsors understand their options, shape fit-for-purpose solutions, and move forward with confidence.
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.
The Director will also contribute to thought leadership and market awareness in managed access regulatory strategy. This may include monitoring global regulatory developments, contributing to internal education, supporting conference or publication opportunities, and helping strengthen IQVIA's position as a strategic partner in patient access and managed access regulatory consulting.
Requirements
- 10 or more years of relevant experience in regulatory affairs, regulatory strategy, managed access, patient access, clinical development, or a 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.
- Bachelor's degree required in life sciences, pharmacy, public health, regulatory affairs, health policy, or a related discipline.
- Advanced degree preferred, such as an MS, MPH, PharmD, PhD, JD, or MBA.
- Equivalent applied experience in managed access, regulatory strategy, or patient access consulting may be considered where appropriate.
The potential base pay range for this role, when annualized, is $140,200.00 - $390,600.00.