Skip to main content

The importance of Regulatory Affairs in drug manufacturing

Kathryn Taylor our consultant managing the role
Published on 16 August 2022

The pharmaceutical industry operates in an increasingly complex regulatory landscape. New scientific developments and technological advances mean that legislation are constantly adapting, and Regulatory Affairs professionals play a crucial role in helping drug manufacturing comply with these changes. Without them, life enhancing drugs cannot be safely and compliantly brought to market.

What does a Regulatory Affairs professional do?

Regulatory Affairs are the safeguard of the pharmaceutical industry. They are protectors of public health and provide an interface between pharmaceutical companies, regulatory bodies and consumers. They give evidenced, strategic advice to pharmaceutical companies on the legal and scientific requirements needed to ensure safe and efficacious drugs are produced.

From initial development through to commercialisation, drug manufacturing is an incredibly lengthy process, and Regulatory Affairs professionals are involved at every stage. In fact, obtaining approval for the initial research and development of a drug would not be possible without the involvement of Regulatory Affairs.

Some of their responsibilities include:

·         Advise scientists and manufacturers on regulations and legal requirements

·         Apply for and obtain product licenses

·         Write product labels and patient information leaflets

·         Plan and develop clinical trials and product trials

·         Analyse and interpret clinical and product trial data

·         Work closely with external regulatory bodies

·         Keep abreast of everchanging legislations and update company guidelines accordingly

Keeping up with legislation

Innovation in Life Sciences is advancing at extraordinary pace, meaning that the legal and governmental guidelines are constantly changing. It is a vital element to a Regulatory Affairs job to stay up to date with the latest news and trends so that the vaccines and medications being manufactured comply with the latest drug safety legislation.

Currently, digitisation of data and processes is having a huge impact on how pharmaceutical companies operate. The race to develop a Covid vaccine demonstrated the true power of Machine Learning and Artificial Intelligence in getting swift and effective results, as demonstrated by Pfizer, Moderna and Johnson & Johnson who successfully applied their technologies in the production of their vaccines.

In the data driven world of Regulatory Affairs, Blockchain and AI technologies are being embraced to help process vast quantities of data to make faster, better drug safety decisions. As such, sourcing related technology and software skills are now becoming a priority when recruiting new Regulatory Affairs talent in the industry.

Regulatory Affairs Jobs

Because of the complexity of the industry, Regulatory Affairs jobs are diverse and offer great flexibility – from working as a contractor, to climbing the ladder through a big pharmaceutical organisation.

Entry level jobs such as a Regulatory Affairs Associate will serve as more administrative functions, collecting and reporting on data, whereas Regulatory Affairs Managers and Heads of Departments will review, strategically plan and liaise with regulatory bodies and clients.

There are several specialty routes that a Regulatory Affairs professional can follow across the scope of drug safety, including:

·         Regulatory Intelligence

·         Regulatory Operations

·         Labelling

·         Medical Devices

·         Chemistry, Manufacturing and Controls

Start your Regulatory Affairs Career

No one understands the importance of Regulatory Affairs in ensuring maximum drug safety better than Quanta. Our specialist Life Sciences recruitment team have a successful track record of placing candidates in Regulatory Affairs and Pharmacovigilance roles and continue to adapt to the growing demand of the market. If you are looking at starting or advancing your career in a new Regulatory Affairs job, reach out to the team today, or scroll our life sciences jobs here.