Director, Managed Access Regulatory Strategy

Overview
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. This 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. 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.

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.

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 IQVIAs 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 IQVIAs 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.
• Bachelors 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.

Strong candidates will be comfortable operating in a growth-oriented environment partnering with commercial and delivery colleagues and bringing structure to emerging client needs. The role is well suited for someone who enjoys both strategic regulatory problem-solving and the opportunity to help build a practical market-relevant offering with clear value for sponsors and patients.

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.