Regulatory Affairs Managers

Regulatory affairs managers make sure that companies' products, operations, and policies are in compliance with industry and federal regulations and rules. Depending on the size of their employer, they may oversee a team of regulatory affairs analysts and report to regulatory affairs directors and department heads. They work for many different industries, including aerospace and defense, biotechnology, business services, construction, education, government, energy and utilities, financial services, health care, hospitality, insurance, manufacturing durable and nondurable, pharmaceuticals, retail and wholesale, software, telecom, and transportation.

Regulatory affairs managers prepare and submit regulatory agency reports, applications, and correspondence. They keep up with current regulations as well as proposed regulations. They share regulatory information with different departments and make sure the information is understood and interpreted correctly. Regulatory affairs managers also develop and implement regulatory policies and procedures to maintain regulatory compliance. They provide regulatory guidance to various project teams involved in the development, design, evaluation, and marketing of products. They also review complaints about products, preparing documentation, reports, and other materials and submitting to regulatory agencies.

Other tasks that regulatory affairs managers may be responsible for include developing and overseeing the procedures for standard operations or local working practices. They may help to develop and implement the protocols for clinical trials. They may appear before domestic or international regulatory agencies to represent organizations on major policy issues or decisions regarding company products. 

Regulatory affairs managers use many different types of computer software programs in their work for research, project management, and report creation. They use compliance software programs such as Aris Global Register and MediRegs Regulation and Reimbursement Suite; document management software such as Adlib Express and Adobe Acrobat; database enterprise user interface and query software such as Microsoft Access and Structured Query Language; enterprise resource planning software such as SAP; and project management software such as Microsoft Project and SharePoint.