A senior regulatory affairs specialist helps their organization navigate the regulatory life cycle of a product or project. First and foremost, the specialist must have an extensive knowledge of state and federal regulations. Due to the technical nature of most products and projects, the senior regulatory affairs specialist must also be well educated about the product(s) or projects being completed.
Armed with information about the product or project, the senior regulatory affairs specialist prepares necessary paperwork and fills out the applicable government agency's application. After initial disclosure, the specialist keeps the application updated, making any changes and edits as necessary. They also continue to accrue information, so that if the application is denied the company's regulatory strategy may be defended in a lawsuit. Finally, the senior regulatory affairs specialist communicates information about federal and state regulations to different groups in the company.
Senior regulatory affairs specialists work in a variety of fields and deal with a variety of agencies. For example, a senior regulatory affairs specialist for a pharmaceutical company must file all necessary paperwork with the Food and Drug Administration to have a drug approved for public consumption. Alternatively, a senior regulatory affairs specialist for a mining or gas company works with the Environment Protection Agency to receive permits to perform drilling at a site.
A minimum of a bachelor's degree in a relevant discipline is generally required for this position. Previous experience in a similar role is needed as well.