Overview 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 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.
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.
The potential base pay range for this role, when annualized, is $140,200.00 - $390,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
