What is regulatory work?

Question

Zippia Team · Accepted Answer

Regulatory affairs work is an industry that oversees how foods, drugs, and medical products are developed, tested, manufactured, marketed, and distributed to certify that they meet regulatory standards for human use. Regulatory affairs professionals are responsible for ensuring manufacturers' compliance.

Regulatory affairs professionals ensure that all applicable global legislative and regulatory requirements are adhered to at each stage of product development.

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.

This means that 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.

A common role in the regulatory affairs industry is that of a regulatory affairs specialist. Regulatory affairs specialists analyze new and existing regulations concerning an organization's products or processes.

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.