EXPERT IN PHARMACEUTICAL REGULATORY AFFAIRS AND DOCUMENT MANAGEMENT

Abstract: Pharmaceutical regulatory affairs experts specializing in document management play a crucial role in ensuring that pharmaceutical products comply with regulatory standards across various jurisdictions. These professionals are responsible for managing the preparation, submission, and maintenance of essential regulatory documents, which include dossiers, applications, and other key regulatory submissions. This article explores the key competencies and responsibilities of pharmaceutical regulatory affairs experts in document management, the importance of proper documentation in the regulatory process, and the challenges they face. Additionally, the paper examines the impact of technological advancements in document management on the pharmaceutical regulatory landscape.