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Regulatory Affairs Specialists

The Job

Regulatory affairs specialists make sure that companies' products and services are in compliance with regulations and laws. They work for various industries, including pharmaceuticals, biotechnology, food science, health care, hospitals, government agencies, academic institutions, and legal, research, and marketing firms.

Specialists stay up to date on existing and emerging regulations, and keep their companies' upper management informed of these regulations. They gather and review data and prepare reports to present to management before submitting to the appropriate regulatory agencies. They coordinate and document regulatory processes such as internal audits, inspections, license renewals, or registartions.

A great deal of regulatory affairs specialists' work entails reading and reviewing documentation, such as case files and research reports. They review existing and new regulations and analyze the effects these regulations may have on their companies' products or processes. They create reports and make presentations on their findings to the companies' management and stakeholders, sharing the potential legal and financial repercussions and discussing steps that can be taken for compliance. Specialists also review product promotional materials, specification sheets, test methods, labeling, and batch records to make sure these are in compliance with regulations and policies.

Regulatory affairs specialists use a variety of computer software programs for their work. Some examples include analytical or scientific software, such as Analyse-it; business intelligence and data analysis software, like MicroStrategy, Qlik Sense, and QlikView; and medical software such as Healthcare common procedure coding system (HCPCS). They also use database user interface and query software, including FileMaker Pro, Microsoft Access, and Structured Query Language (SQL); and document management software such as Adobe Acrobat and Atrion Intelligent Authoring.

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