Director, Managed Access Regulatory Strategy

Location: Falls Church, Virginia, United States of America

Salary: $140,200–$390,600 annualized base pay, with potential incentives, bonuses, and additional benefits depending on the position.

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Develop regulatory strategies for Expanded Access Programs, Post-Trial Access, Open Label Extension studies, compassionate use, and named patient initiatives.
• Advise pharmaceutical and biotechnology sponsors on global access pathways, country-specific requirements, product labeling, and import/export considerations.
• Serve as a senior subject matter expert in client discussions, proposals, bid defense activities, and active engagements.
• Partner with account, regulatory, clinical, real-world, and operational teams to identify, shape, price, and sell client opportunities.
• Build methodologies, templates, best practices, proposal language, pricing approaches, and delivery models for managed access services.
• Monitor regulatory developments, support internal education, and contribute to thought leadership, conferences, and publications.

Requirements

• At least 10 years of relevant experience in regulatory affairs, regulatory strategy, managed access, patient access, clinical development, or pharmaceutical services.
• Experience with Expanded Access Programs, Post-Trial Access, Open Label Extension studies, compassionate use, named patient programs, or similar access pathways.
• Strong understanding of global regulatory requirements for investigational therapies, including labeling, country-specific requirements, and import/export considerations.
• Experience engaging clients, uncovering needs, shaping solutions, supporting proposals, and clearly communicating complex regulatory issues.
• Bachelor’s degree in life sciences, pharmacy, public health, regulatory affairs, health policy, or a related discipline.
• Experience across regulatory, clinical operations, supply, real-world evidence, pharmacovigilance, commercial, and medical stakeholders is relevant; an advanced degree is preferred.

Nice to have

• Client-facing consulting, business development, proposal support, solution shaping, pricing, or sales experience.
• Experience with a managed access provider, CRO, pharmaceutical or biotechnology company, or regulatory consulting organization.
• Advanced degree such as an MS, MPH, PharmD, PhD, JD, or MBA.

Culture & Benefits

• Growth-oriented environment focused on developing a market-relevant managed access capability.
• Cross-functional collaboration with commercial and delivery colleagues.
• Opportunities to contribute to internal education, conferences, publications, and regulatory thought leadership.
• Potential incentive plans, bonuses, and health and welfare benefits may be available depending on the position.