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Pharmaceutical Regulatory Affairs

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 is constantly adapting, and Regulatory Affairs professionals play a crucial role in helping drug manufacturing comply with these changes. 

Life-enhancing drugs cannot be safely and compliantly brought to market without them.

Continue reading to learn more about pharmaceutical regulatory affairs.

What Does a Pharmaceutical Regulatory Affairs Professional Do?

Regulatory Affairs are the safeguard of the pharmaceutical industry. They protect public health and provide an interface between pharmaceutical companies, regulatory bodies and consumers. 

They give evidence-based, strategic advice to pharmaceutical companies on the legal and scientific requirements needed to ensure safe and efficacious drugs are produced.

From initial development to commercialisation, drug manufacturing is an incredibly lengthy process, and Regulatory Affairs professionals are involved at every stage. 

Obtaining approval for the initial research and development of a drug is only possible with 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 legislation and update company guidelines accordingly

Keeping Up With Legislation

Innovation in Life Sciences is advancing at an extraordinary pace, meaning that the legal and governmental guidelines are constantly changing. 

It is vital to a Regulatory Affairs job to stay updated with the latest news and trends so that the vaccines and medications being manufactured comply with the latest drug safety legislation.

The digitisation of data and processes greatly impacts pharmaceutical companies' operations. 

The race to develop a COVID-19 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 producing 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 is becoming a priority when recruiting new Regulatory Affairs talent.

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 speciality 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 Pharmaceutical 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 has a successful track record of placing candidates in Regulatory Affairs and Pharmacovigilance roles and continues to adapt to the market's growing demand. 

If you are looking at starting or advancing your career in a new Regulatory Affairs job, reach out to the team today or scroll through our life sciences jobs here. 

View here to see the latest Manufacturing Science Tech jobs.