Regulatory affairs are an executive role in regulated industries, such as banking, telecommunications, securities trading, and especially in the industries regulated by the US Food and Drugs Administration (FDA). Every producer and every distributor of pharmaceuticals, veterinary medicines, medical devices, biologics, and functional foods is regulated by the FDA. All of these businesses, whether they are regulated by the FDA, EPA, FTC, or other agencies, have regulatory affairs officers.

The role of regulatory affairs is especially prominent in the pharmaceutical, medical devices, and food science industries. FDA approvals are essential for financial returns in any amount on products and processes that can cost hundreds of millions of dollars to create. In these industries, regulatory affairs officers also must be able to navigate the laws, rules, and regulations of health authorities in multiple foreign countries to export to their markets.

Why Do We Have Government Regulation?

Government regulation of the pharmaceutical, food, and consumer products industries was unknown before the beginning of the twentieth century. A series of high-profile disasters led to the public's demands for the regulatory agencies we have today.

The deaths of 22 children who had received defective diphtheria vaccines led to the Biologics Control Act of 1902. The horrors of the food and drug industry exposed in Upton Sinclair's bestselling book The Jungle led to the Pure Food and Drugs Act of 1906. When an improperly prepared antibiotic known as Elixir Sulfanilamide led to the deaths of 100 people in 1937, the Food and Drug Cosmetic Act followed in 1938. The births of thousands of babies with deformed or missing arms and legs after their mothers took thalidomide led to the Kefauver Harris Amendments in 1962, and injuries to 16,000 women by the contraceptive Dalkon Shield was followed by Medical Device Amendments of 1976. Defects in the Björk–Shiley heart valves led to the Safe Medical Devices Act of 1990.

Similar concerns have led to the formation of regulatory agencies in the UK, the European Union, Japan, Australia, Latin America, East Asia, and countries all over the world. Almost every government in the world has regulatory agencies to prevent public health disasters caused by defective medicines, medical devices, and food. Regulatory affairs officers make sure that their companies are working with the government to prevent the next public health crisis.

What Does a Regulatory Affairs Officer Do?

Most regulatory affairs officers are employed by regulated industries, such as companies that make food and beverages, medical devices, and pharmaceuticals. They interact directly with regulatory agencies, such as the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and the Federal Trade Commission (FTC). Their precise duties depend on the industry in which they work, since each industry has its own set of regulations.

The duties of regulatory affairs officers also vary with the size of the companies they work for. Regulatory affairs officers in large companies may have narrowly defined duties, allowing them to develop in-depth expertise that will help the company research, develop, manufacture, and market a single product. Regulatory affairs officers in smaller companies may work in small teams on multiple products, taking a flexible approach to their job duties.

Some of the most common tasks performed by regulatory affairs officers include:

• Maintaining an in-depth and up-to-date understanding of federal, state, and international regulations that affect their company's products and processes.
• Explaining regulations, procedures, and policies to all stakeholders, including both employees of the company and representatives of the agencies that regulate them.
• Keeping records for future reference, and for audit by the regulatory agencies. Following government regulation and legal rules of evidence regarding preservation and deletion of files.
• Using their understanding of the regulatory environment to create standard operating procedures for the entire company, communicated in clear, documented protocols.
• Reviewing technical, marketing, and legal documents to ensure compliance with relevant regulations.
• Conducting regular audits of company processes and protocols to ensure regulatory compliance and taking corrective action when necessary.
• Preparing for third-party audits, whether by government agencies or for preparation of required reports.
• Reporting on compliance to company management and stakeholders outside the company.
• Acting as a liaison between the company and local, state, federal, and international regulatory agencies, submitting required forms and reports, and communicating orally and in writing with regulators.

Core Competencies of Regulatory Affairs Officers

There is no single, required career path for regulatory affairs officers. Regulatory affairs officers come into the field from diverse backgrounds, ranging from biomedical research to marketing and journalism. All regulatory affairs officers, however, must have the technical proficiency to understand the products their companies make that are subject to government regulation. They also need a variety of executive skills.

Regulatory affairs officers must be attentive to detail. One missed step can result in the disapproval of years of research and development. One mistake in a required filing can result in a product being pulled off the market. Attention to detail can save lives, as well as the company's reputation.

Regulatory affairs officers must have basic analytical skills. They need to be able to recognize patterns and potential liabilities in order to communicate with the data analysts who quantify their concerns.

Regulatory affairs officers must have strong communications skills. Regulatory expertise is useless without the ability to communicate with managers, employees, vendors, suppliers, and representatives of the regulatory agencies.

Regulatory affairs officers must have project management skills. They must be able to assemble information from multiple sources to achieve compliance, particularly in the research and development stage of a product.

Regulatory affairs officers need a deep understanding of their companies, their products, and the industry in which they compete. And they need a sense of mission to protect their companies and consumers from harm.

There is no sequence of college courses required for becoming a regulatory affairs specialist, although some universities offer advanced degrees in regulatory affairs. The Regulatory Affairs Professionals Society (RAPS) offers post-graduate certifications as a credential of regulatory excellence that is often appreciated by employers.

Fladger Associates matches regulatory affairs professionals to jobs where they can excel. Call us at 302-836-3100 or contact us online for more information about our executive recruitment services.