The regulatory affairs role in the pharmaceutical industry is rapidly changing, with many of the tasks once aligned with in-house experts being outsourced or automated by developing technology. This trend is forcing industry professionals to rethink their role and establish themselves as thought leaders who bring measurable strategic value to their company’s business. This insight brief examines the shift of regulatory affairs work to local hubs, which is creating new opportunities for regulatory professionals to work directly with regulators, provide thought leadership input within their respective organizations, and support product development as the profession continues to evolve. Based on market leadership with over 7,000 product registrations serviced in over 150 countries since 2015, this insight brief shares global regulatory affairs insights from IQVIA with partner Bristol-Myers Squibb on the evolution and anticipated future of the regulatory affairs profession and industry.
Introduction: The Long view
在过去的几十年中，监管事务功能的轨迹已演变为当前在开发轮枢纽和研发动态引擎中的位置（图1）。在外包监管事务任务方面，我们可以回顾十年左右的数据管理和生物统计学功能，这些功能主要是基于国家或地区的，在许多不同的地理学中进行的类似工作。相比之下，如今，这些职能中的许多员工都位于近海，并由通常位于发达国家的全球项目经理协调。此外，我们看到源自公司以外的化合物的迅速加速，最终负责营销它们。十年前，大型制药公司出售的批准药物中有三分之一来自其组织外部。如今，这已经上升到51％至70％。
过去和现在
十年前，一位监管事务专家可以期望从公司的总部或区域会员担任角色，从事监管事务的各个方面，仅涵盖特定于国家或地区的项目。
如今，随着外包部门的成熟以及技术和流程的发展，监管事务专业正在发生变化。必威官方在线现在，监管事务专业人员通常专注于单个子过程，通常从事孤岛工作，并有不完全了解整个产品开发范围的风险。
