Director, Managed Access Regulatory Strategy

The Director, Managed Access Regulatory Strategy will help build a regulatory strategy offering supporting patient access programs for investigational therapies outside of traditional clinical trial settings. The role requires someone who can translate client needs into compelling proposals, partner with account and delivery teams to sell the solution, and bring practical regulatory insight into early opportunity discussions.

What You Will Do

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.

Why It Might Be a Fit

The successful candidate will bring experience in managed access, expanded access, post-trial access, compassionate use, open label extension, or related regulatory strategy work. They should be energized by the opportunity to help grow a new capability, engage directly with clients, support business development, and contribute to practical solutions that improve patient access to investigational therapies.

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.

Benefits

• Dental insurance
• Vision insurance
• Health insurance
• 401(k) or retirement plan
• Paid time off (vacation, sick leave)
• Other benefits dependent on the position offered