Pharma regulatory affairs professionals play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry.
The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:
In vitro diagnostics
Biologics and biotechnology
The regulatory professional’s roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and post market surveillance.
Ensures all company products meet worldwide regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Responsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and international regulations/ interpretations. This may include the review, evaluation, and compilation of files and reports for submissions. Provides project team representation and direction in managing information from/to other departments (including R&D, Manufacturing, Quality Assurance, Quality Control, Medical Affairs, Marketing, and Clinical Affairs) regarding Regulatory submissions.
his may include the preparation of outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments. Reviews technical and clinical documentation and recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration. Is responsible for the timely completion of regulatory projects and submission of documentation to regulatory agencies. Develops and maintains current regulatory knowledge and keeps abreast of regulatory procedures and changes. May provide regulatory guidance to project teams and junior staff.