Pharmaceutical regulatory professionals have a key role to play in ensuring that all pharmaceutical products comply with industry regulations. The regulatory function in the healthcare sector is vital to ensuring that safe and effective healthcare products are available worldwide.
Individuals who ensure regulatory compliance and prepare submissions, as well as those whose primary 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:
- Medical devices
- In vitro diagnostics
- Biologics and biotechnology
- Nutritional products
- Veterinary products
The roles and responsibilities of regulatory professionals often begin in the research and development phases, move into clinical trials and extend through pre-market approvals, manufacturing, labeling and advertising, and post-market surveillance.
Regulatory Affairs Associate
Ensures that all company goods comply with global regulatory requirements by promoting all related regulatory aspects of product approval and post-market enforcement. Responsible for arranging and assembling packages for regulatory applications to ensure compliance with the Food and Drug Administration (FDA) and international regulations / interpretations. This may include the analysis, evaluation, and compilation of application files and reports. Provides support and guidance to the project team in handling knowledge from / to other departments (including R&D, Production, Quality Assurance, Quality Control, Medical Affairs, Marketing and Clinical Affairs) on regulatory submissions.
These may include the preparation of outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments. Reviews the technical and clinical documentation and recommends adjustments to the labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Researches and analyzes regulatory information and determines the acceptability of data, processes and other product related documentation submitted in support of product registration. It is responsible for the timely completion of regulatory projects and the submission of documentation to regulatory agencies. Develops and retains current regulatory awareness and keeps pace with regulatory procedures and changes. May provide regulatory guidelines for project teams and junior staff.