管理访问监管策略总监
Director, Managed Access Regulatory Strategy
职位名称：管理准入监管策略总监
工作地点：美国北卡罗来纳州达勒姆
工作地点类型：远程
工作合同类型：全职
职位级别：
简介
IQVIA 正在寻找一名管理准入监管策略总监，以帮助建立支持研究性疗法在传统临床试验之外的患者准入计划的监管策略方案。该职位将支持扩展准入计划、试验后准入、开放标签延长研究、同情使用计划、指定患者计划、全球标签考虑因素以及进出口监管要求。
该总监将作为高级客户面向的监管策略专家，帮助制药和生物技术赞助商了解其选择，制定适合需求的解决方案，并充满信心地推进。该职位需要能够将客户需求转化为有说服力的提案，与客户经理和交付团队合作销售解决方案，并在早期机会讨论中提供实际的监管见解。
成功的候选人应具备管理准入、扩展准入、试验后准入、同情使用、开放标签延长或相关监管策略工作的经验。他们应热衷于帮助发展新能力，直接与客户互动，支持业务开发，并为改善研究性疗法的患者准入做出实际解决方案的贡献。
职责
- 支持扩展准入计划、试验后准入、开放标签延长研究、同情使用和指定患者准入计划的监管策略。
- 为支持研究性疗法准入的全球路径提供建议。
- 提供关于国家特定要求、产品标签、进出口考虑因素和跨境准入需求的指导。
- 在客户讨论、提案和投标防御活动中担任可信的主题专家。
- 与客户经理、监管、真实世界、临床和运营团队合作，识别、塑造、定价和销售新的客户机会。
- 帮助完善 IQVIA 支持管理准入和患者准入计划的监管服务方案。
- 为 EAP、PTA、OLE、标签和进出口项目贡献实用的方法论、模板、最佳实践、定价方法、提案语言和交付模式。
- 在 IQVIA 各团队之间协作，以确保监管合规性。
查看英文原文
Job Title: Director, Managed Access Regulatory Strategy
Job Location: Durham, North Carolina, United States of America
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
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 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.
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.
IQVIA 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.
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.
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Originally posted on Himalayas