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Health & Social Care

Regulatory Affairs Officer

Job Description

Okay, so the name might sound a bit dry, but regulatory affairs officers have pretty important jobs. These guys work for research organisations, medical, pharmaceutical, chemicals and other alternative medicines manufacturers to ensure that what their company produces complies with registration.

In a nutshell, regulatory affairs officers ensure manufactured products are appropriately licensed, produced and marketed.

Without this lot, the shelves of Boots, pharmacists and… um… fertiliser stores would be empty. Why? Because they are part of the process that ensures the chemical and medical products we buy and use are safe and work.

Without their expertise, products wouldn’t pass regulations set by regulatory bodies, such as the Medicines and Healthcare products Regulatory Agency (MHRA), and we wouldn’t be able to buy them.

Regulatory affairs officers are there at nearly every stage in a product’s life span: from conducting and devising product trials, to getting licenses for the product and ensuring it meets regulations, to actually writing the product labels and accompanying information leaflets.

In a sense, they are the go-between, negotiating between the company they work for and the appropriate regulatory body to ensure that their product meets all the necessary regulations.

It’s a job that requires a unique blend of scientific, legal and business knowledge, as regulatory affairs officers spend much of their time at desks scrutinising scientific and legal documents. 

Salary & benefits

Those starting in assistant and junior roles might command salaries between £18,000 and £24,000, whilst regulatory affairs officers with more experience are looking at yearly earnings between £28,000 and £50,000.

After ten years, regulatory affairs officers in the most senior roles might earn a salary of anything between £40,000 and £100,000 a year. 

Working hours

Working hours are pretty regular, but officers might work overtime to meet product and license deadlines. 

Entry

This is a graduate-level job. Most employers will be looking for candidates with degrees in the sciences, such as in pharmacy, biochemistry, chemical and physical sciences, medicinal chemistry, biotechnology and biomedical science. Some might prefer candidates who are educated to a PhD level.

Most candidates will have previous experience under their belts, such as working as a regulatory affairs assistant or in other areas, such as research or quality assurance.

Do you have the makings of a regulatory affairs officer? You’ll need a solid scientific and legal understanding, have top analytical and problem solving skills and winning written and oral communication skills. You’ll need to be super organised and happy to work to strict deadlines. People skills and the ability to network and negotiate are a must. Fluency in another language will be useful. 

Training & progression

Although there is no formal training, with many learning ‘on-the-job’ or through in-house training, gaining a diploma and MSc in Regulatory Affairs from The Organisation for Professionals in Regulatory Affairs (TOPRA) is increasingly seen as important for career progression, but is by no means mandatory.

Training never really stops for a regulatory affairs officer, as they have to continuously keep abreast of changes in regulatory matters and new research and scientific developments.

In terms of career progression, regulatory affairs officers might look to progress to more senior managerial roles (although there might not be much scope for promotion in smaller companies with only one or two regulatory specialists) or to specialise in certain areas.

Some regulatory affairs officers go on to set up their own consultancies or work as freelancers.