What Does a Regulatory Affairs Specialist Do?

A regulatory affairs specialist is responsible for ensuring that a company’s products comply with all relevant regulations and laws in the regions where they are sold. They provide expert scientific and business advice and act as a liaison between the organisation, the products they sell and the regulatory authorities.

 

Regulatory Affairs Specialist: Duties & Responsibilities

Documentation

One key duty of a regulatory affairs specialist is to assist in reviewing legal, marketing and product documents (including case files and clinical research reports) to assess compliance. Regulatory affairs specialists will also need to prepare and submit any necessary documentation to regulatory agencies alongside carefully maintaining data and files for future audits. 

 

Product Trials

Another key aspect of being a regulatory affairs specialist is gathering, evaluating and managing scientific and regulatory data. They are responsible for planning and developing product trials and interpreting the trial data. Sometimes they will also be tasked with developing and approving product labels and information leaflets, as well as taking part in marketing activities for packaging and advertising. 

 

Regulatory Strategy

Regulatory affairs specialists are also responsible for handling everything relating to regulation. They must have a deep understanding of new and existing regulations that may impact their organisation’s products and processes. They can then use this understanding to provide strategic advice to senior management on regulatory matters and ensure that products meet legal requirements for safety, quality and efficacy. 

 

What Skills & Qualifications Does a Regulatory Affairs Specialist Need?

Regulatory affairs specialists need to have excellent attention to detail, as one misstep can put lives and the organisation’s reputation at risk. They will also need to have strong project and time management skills and be able to work under pressure and to tight deadlines.

Excellent communication skills are also required in order to effectively communicate with regulatory authorities and other team members.

In order to become a regulatory affairs specialist, you will usually be required to have a bachelor’s degree in a related field such as product safety, biology, chemistry or engineering. However, regulatory affairs can be especially challenging to break into, so most candidates will need a few years of experience in a related role and some employers may require a master’s degree.

If you would like more expert advice and support on securing roles in the life science industry, please don’t hesitate to contact Hyper Recruitment Solutions today!