Role of the Regulatory Professional [1.0 RAC]

Regulatory professionals play a critical role in the advancement of healthcare. The regulatory professional must work closely with both internal and external stakeholders to ensure health products are developed and maintained in compliance with all applicable country regulations from development, through post-approval, to the ultimate discontinuation of the product. Externally, the regulatory professional’s job is to understand and navigate the ever-changing regulations in all countries in which the company wishes to distribute its products. Internally, the regulatory professional must drive alignment across many functions to ensure the proper technical information is available for presentation to regulatory agencies. If the regulatory professional understands the regulations, and successfully aligns internally to develop the proper submission, they will then be able to successfully submit and carry out all subsequent negotiations necessary to obtain and maintain marketing authorization for the products concerned.

Regulatory is a dynamic discipline that brings the individual into contact with almost all of a company’s various departments and disciplines. Regulatory professionals also advise on legal and scientific constraints and requirements and collect, collate and evaluate scientific data generated by research and development colleagues. In their companies, they also give strategic and technical advice at the highest levels, making important contributions - both commercially and scientifically - to the success not only of a development program, but to the company overall.

This course discusses the evolution of the regulatory profession, the professional’s roles and responsibilities and normal roles available within a regulatory organization. It also briefly outlines the critical events and their impact for each product lifecycle stage for drugs, biologics and medical devices.