Regulatory Affairs

The regulatory affairs function of a Pharmaceutical and biotech company ensures legal compliance. Learn all about working in regulatory affairs.

What does regulatory affairs mean?

Regulatory affairs in pharma means securing approval for new drugs and treatments. This ensures that the products have legal permission to be released on the market for sale. The regulatory affairs department acts as an intermediary between the company’s project teams and the regulatory bodies.

What does a regulatory affairs professional do?

As a regulatory affairs professional you are responsible for ensuring that every product your pharmaceutical, biotechnology or medical device company sells has the relevant licences. Patient safety and product effectiveness are key. Rules and regulations across the globe keep changing, so it is essential that you are on top of these and understand the impact on your company. Your job also includes maintaining efficient communication channels. This ensures that anything that falls under regulatory affairs, such as approval processes, runs smoothly. You might work as a Regulatory Affairs Manager or a Regulatory Affairs Officer, and be involved in:

• used with trial master files (TMF) and electronic trial master files (eTMF);
• planning which markets to sell your products in;
• proactively investigating upcoming legislative changes;
• guiding your company through the ever-changing legislative landscape;
• helping your business encourage best practice and regulatory compliance;
• ensuring all relevant documentation is submitted to regulatory authorities.

Popular job titles within Regulatory Affairs

What is it like working in the area of regulatory affairs?

Working in regulatory affairs varies according to the size and type of organisation you are working for. For example, this may be a pharmaceutical company, a clinical research organisation, a consultancy or even one of the regulatory bodies itself. Larger organisations will have a bigger department, which may be divided into different specialisms. A smaller organisation will have fewer staff. Here, you are likely to come across a variety of different tasks in different specialisms in regulatory affairs. This will help to broaden and develop your experience.

Where can a career in regulatory affairs take me?

A career in regulatory affairs can provide you with a broad range of opportunities, with the potential to work in multiple capacities. Are you passionate about working in regulatory affairs in pharma? Would you be interested a job where you are helping with the registration procedure and in obtaining trading licences for medicines? Would you like to optimise the texts in package leaflets to make patient information more universally understood? Do you want to be the crucial link between the pharmaceutical company and the regulatory bodies? Can you translate the requirements of the US and European regulations to local legislation? Then this could be the right job for you!

Entry level regulatory affairs jobs may be available as a Regulatory Affairs Officer (also known as a Regulatory Affairs Associate). You can rise to more senior roles as you become more experienced.