Director, Managed Access Regulatory Strategy

The Director, Managed Access Regulatory Strategy will support regulatory strategy for Expanded Access Programs, Post-Trial Access, Open Label Extension studies, compassionate use, and named patient access initiatives. They will advise sponsors on global pathways supporting access to investigational therapies and provide guidance on country-specific requirements, product labeling, import/export considerations, and cross-border access needs.

What You Will Do

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. They will support regulatory strategy, advise on global pathways, and provide guidance on country-specific requirements.

Why It Might Be a Fit

The successful candidate will bring experience in managed access, expanded access, post-trial access, compassionate use, 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 and welfare benefits
• Other benefits