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What Does a Regulatory Officer Do?

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  • Written By: R. Stamm
  • Edited By: Lauren Fritsky
  • Last Modified Date: 20 November 2016
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A regulatory officer assists companies of various types with regulation and licensing laws to ensure that new products meet the requirements set forth by consumer and government agencies. This person is a critical link between the manufacturer, the government, and consumer. This individual has vast experience in legal and business issues and is knowledgeable about scientific matters. A person in this position possesses a diverse skill set and has a high level of scientific education.

The primary function of a regulatory officer includes studying scientific and legal documents to ensure that products are in compliance with governmental regulations. The individual is familiar with changes in regulatory legislation and relates these changes to scientists and manufacturers. An officer reviews and prepares regulatory documents and ensures that quality standards are met. An officer is responsible for filing and submitting these documents in a timely manner.

A person in this position is also responsible for gathering, evaluating, organizing, and collating information in a variety of formats. In order to complete these tasks, the regulatory officer has extensive knowledge in a number of computer specialist applications. The individual uses these applications to coordinate product trials and oversees regulatory inspections. In addition, an officer uses computer applications to analyze trails data and other complex information.

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In addition to understanding the laws and computer programs, a regulatory officer acts as a consultant to the companies. An officer provides advice about company policies, practices and systems. The individual offers advice about governmental regulations to manufacturers and scientists. A person in this position may assist and advise in marketing plans for new products, and then obtain marketing authorization from the proper authorities. Once the consultations are complete, the officer writes coherent, clear product information and labels to pass on to the consumer.

Certain skills are required to perform the functions of this position effectively. A regulatory officer has excellent communication and interpersonal skills used for negotiating contracts and presenting related material to the proper departments. The individual is capable of analyzing complex data pertaining to laws and products, and can easily solve problems related to these areas. Organizational and time management skills are indispensable in this position, combined with extensive knowledge in Information Technology (IT).

Companies require candidates to have at least a bachelor's degree in a science-related field to obtain a position as a regulatory officer. Most companies prefer to hire individuals with a doctorate in a science-related field such as pharmaceuticals, chemistry, biochemistry, or any of the biomedical fields. Persons with prior regulatory affairs experience are appealing candidates for employment in this position. It is also useful to gain as much experience in an entry-level position as possible before applying for an officer's position.

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