Because the field of global regulatory affairs spans a diverse set of disciplines, including law, economics, public policy, health, and science, the scope of a regulatory professional’s work varies. Career paths and daily responsibilities may differ based on areas of expertise, but all regulatory professionals have one goal in common: to facilitate the commercialization of safe and effective products and services. Some regulatory affairs professionals manage clinical studies or develop marketing approval policies, while others design labels for food- and drug-related products.
One of the most common titles in the industry is regulatory affairs specialist. These specialists analyze new and existing regulations in relation to an organization’s products or processes. They also review marketing, legal, and technical documentation, including case files and clinical research reports, to assess compliance with global regulatory agency policies, regulations, and standards. Regulatory affairs specialists may also recommend courses of remediation to help companies achieve the necessary levels of compliance. Acting as a liaison between manufacturing organizations and federal agencies, they may be responsible for submitting critical regulatory documents, with the goal of approval for sale and distribution.
Senior-level regulatory professionals often make strategic business decisions that have significant legal and financial repercussions. A large part of a regulatory affairs role, at all levels, is to interpret and communicate these implications to a diverse set of internal and external stakeholders.