Have you ever considered working regulatory affairs? A career in regulatory affairs can provide rewarding and exciting opportunities, but it can be a challenging area into break as most roles require previous experience. Here's our advice about how to get your foot on the ladder and start your career in regulatory affairs.

What is regulatory affairs?

Regulatory affairs plays a vital role in any life science company as ensures the safe and effective making of healthcare products, including pharmaceuticals and medical devices. Companies responsible for the creating, manufacturing and marketing of medical products have a duty to certify that the products they produce are fit for purpose and make a valuable contribution to health and wellbeing.

What does a regulatory affairs professional do?

It is the responsibility of regulatory affairs professional to keep abreast of the ever-changing legislation and guidelines in which their company operates in as they are required to give strategic advice on the legal and scientific requirements that products must meet. A regulatory affairs professional will be in charge of collecting, collating and evaluating data as well as being responsible for registration documents and carrying out any necessary negotiations that affect a product’s market authorisation.

Furthermore, a regulatory affairs department will often be involved in the development of product marketing concepts and is commonly required to approve packaging and advertising before a product goes to market.

What is the demand for regulatory affairs professionals?

Regulatory professionals play an important role and are needed in a wide number of industries including pharmaceuticals, biopharmaceuticals, medical devices, nutrition and cosmetics, and regulatory work is varied in each sector. Skilled regulatory affairs candidates are in high demand and vacancies for senior regulatory positions are easy to find, but many roles require experience and that can be hard to get.

What qualifications or training do I need to do to get a job in regulatory affairs?

As with the beginning any career, your qualifications, skills and experience all play a part in securing your first regulatory affairs job. You would usually be expected to have a bachelor's degree in a life-sciences-related field to start your career in regulatory affairs. If you have not taken a degree in this field; taking on a can help you compete against those that have. In some cases you might be able to get a position as a regulatory affairs administrator without a degree, although this is quite a junior role and further career progression might prove more difficult in the future.

In pharmaceutical regulatory affairs, candidates with pharmacy degrees (PharmD) are generally viewed more favourably than those with degrees that are less specific to drug development. In countries such as France, where the degree is vocational, graduates with a thesis on a regulatory topic and relevant work placements are more highly sought after.

Although a master’s degree not always necessary it can be advantageous. run two regulatory affairs master’s qualifications in conjunction with leading universities: MSc in Regulatory Affairs and MSc in Medical Technology Regulatory Affairs.

Regulatory affairs is a constantly evolving profession that requires ongoing training. Graduates and experienced professionals alike should consider undertaking training courses such as Good Manufacturing Practice. There are also several courses available through TOPRA, including 1-day course and online training.

How can you get the right experience for a regulatory affairs role?

Regulatory affairs jobs often require candidates to have previous industry experience to be considered. Even entry-level regulatory affairs jobs can require up to 2 years of experience in a related field. 

Internships are an excellent way to gain regulatory experience and start to build contacts within the industry. Consider taking a sandwich-year placement if your university offers it as an option and take advantage of the opportunities at your disposal through your university such as graduate development schemes and careers fairs to talk to companies that are looking for science graduates. Generally, larger companies are far better equipped to take-on inexperienced graduates and are more likely to offer programmes such as graduate assessment days and internships. Companies often publish these opportunities on their career websites or social media pages, so follow companies that you would like to work for and keep a close eye on them.

You can also gain experience of regulatory frameworks and improve your technical understanding by starting out in other related field. Entering regulatory affairs in this way might feel like a sideways move or even require you to take a pay-cut in some instances, but this is a short-term sacrifice for long-term gain.

Many pharmaceutical regulatory affairs professionals started their careers working in formulation, product development, pharmaceutical development or other roles that enabled them to gain technical expertise of the drug development process, such as quality assurance, compliance, safety or clinical trials. If you are a registered pharmacist, you can also gain regulatory experience working as a pharmaceutical assessor for the FDA, MHRA, EMA, or equivalent national competent authority in your country.

Candidates working in related fields can still have difficulties, so this is by no means a guaranteed method of entry. If you are looking to move sideways into regulatory affairs, the addition of a regulatory-specific qualification to your CV will have added importance and value. A basic 1-day qualification will make your CV stand out from all the other people who have no experience at all. Among other organisations, TOPRA does a well-recognised entry-level course.

Additionally, it’s important to stay up-to-date with your chosen sector; if you want to work in pharmaceutical regulatory affairs, for example, familiarise yourself with the drug discovery and development process and keep a close eye on pharmaceutical industry news, particularly for regulation changes, drug pipelines and FDA approvals. Even just joining TOPRA, which is now free of charge for undergraduates, enables you to demonstrate a commitment to your regulatory career choice on your CV.

What are the different career paths you can take?

Roles will vary from company to company and industry to industry, but with the right skills and experience, most regulatory professionals will have the chance to climb up the hierarchical ladder all the way to director level. Large companies may have multiple departments that focus on different aspects of regulatory affairs, whereas smaller companies might have just have a small team with broad responsibilities. Regulatory affairs offers a wide range of diverse positions and career pathways. You can have the opportunity to work on anything from labelling to process management.

Common regulatory affairs career paths’

Here are a few examples of how people start their careers in the industry and the different regulatory affairs career paths’ you can take:

Example A: Undertook an internship in a community pharmacy whilst at university studying for a bachelors in pharmaceutical sciences. Upon graduating she went on to work as a quality assurance technician at a small pharma company for 2 years. She then spent short spells over the next 3 years at small pharmaceutical companies working on various projects in QA roles before eventually taking a permanent job as a regulatory affairs officer at a global pharma company. 

Example B: Graduated as a master of pharmacy and became a clinical cardiovascular pharmacist working in a hospital. After 2 years he was able to find a position as a regulatory affairs associate at a top 10 pharmaceutical company. 

Example C: After graduating with a bachelors degree, this candidate had a placement as an analytical chemist whilst undertaking his masters in pharmaceutical analysis. On completing his studies he started working for a large global pharmaceutical company as a quality assurance analyst, ensuring compliance of documentation. After 18 months he was offered a position at another leading pharma company as a regulatory CMC associate.

Our top ProTips for starting your career in regulatory affairs:

Demonstrate attention to detail

One of the key skills that you will need to work in a regulatory role is great attention to detail, so your CV must reflect this. When applying for jobs in regulatory affairs, ensure that your and put emphasis on the key points that you learnt in your studies which are relevant to regulatory affairs.

Tailor your CV

Don't spend time applying for vacancies that are above your level of skills and experience, instead use this time more wisely to tailor your CV to the specific role or company that you want to work for. The most common entry-level regulatory affairs job titles are regulatory affairs administrator, submission coordinator and regulatory affairs associate, although this position can be called a regulatory affairs officer, regulatory affairs executive or regulatory affairs advisor, dependent on the organisation.

Be proactive

Don't rely solely on your job applications though. Remember that not every company will advertise all its vacancies so you should consider other approaches too. Proactively call and email HR departments and talent acquisition teams. Ensure that your LinkedIn profile matches your CV so that you can use it to send messages to employers too.      

Get networking

Network with regulatory professionals and hiring managers to find out about opportunities and make yourself known in the right circles. Attending the TOPRA Annual Symposium is not expensive for graduates but gives you a fantastic opportunity to speak with regulatory professionals and representatives from companies that you can seek advice from. You can register with regulatory affairs recruitment agencies but keep in mind that companies pay recruiters to find them people that they might have difficulty finding for themselves, which is usually the more experienced candidates, so going direct is sometimes the best way when you are looking for an entry role.

 Interested in working in regulatory affairs? Take a look at our regulatory affairs roles and apply today.