Pharmaceutical and Biotech Regulatory Solutions
Regulatory Affairs Officer
Regulatory Services

What Does a Regulatory Affairs Officer Do?

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A Regulatory Affairs Officer is responsible for making sure that medical products have complied with the correct legal rules and have been licensed appropriately

It is their job to make sure that medical products are safe and ethical. If you want to be successful in this job role then you need to have strong legal, scientific and business knowledge. This will enable you to accurately make decisions as to whether a product meets the correct legislation requirements. Each and every product needs to be checked through the various stages of production. Some of these stages might include marketing, development, manufacturing, initial research and distribution. Regulatory Affairs Officers are constant source of valuable advice and information. You need to make sure that you have an in depth knowledge of the life science industry and the specific area in which you work within. Part of the job is to manage communications and become a vital link between your company and regulatory authorities. So what sort of things might a Regulatory Affairs Officer be involved with on a daily basis?

  • They might use IT software to evaluate product quality and produce reports.
  • Identifying packaging needs and requesting the necessary equipment for each product. They need to make sure that the packaging process also complies with industry legislation.
  • Making sure that product labels are very clear and accurate. Labelling a product incorrectly could be potentially ruin a company and have terrible consequences. You cannot afford to make a mistake when it comes to medical products and people’s health.
  • Another important part of the job is to negotiate with authorities. There are certain requirements that have to be met and some that can be adapted and negotiated.
  • It is absolutely essential that RA officers keep up to date with national and international legislation so that they can make informed decisions. If an officer does not know the legislation inside out and consequently start to make mistakes, the company will be in trouble.

As you can see there is a great deal of responsibility in this job role, but if you are determined and dedicated to your job then you will succeed.

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