How to start a career in regulatory affairs in 5 steps
Updated 11 September 2023
If you have attention to detail and an interest in science, law and business, then you may consider a career in regulatory affairs. These professionals are essential to ensuring that companies develop products that are aligned with the legislation set by regulatory authorities. Learning more about this field can help you decide whether it suits your interests, skill set and career goals. In this article, we explore what these professionals do, share their national average salary, explain how you can start your own career in this field, share relevant skills to develop and discuss career prospects.
What do regulatory affairs professionals do?
The role of a regulatory affairs professional can vary depending on your chosen field and the size of the company. These professionals handle the development of such a wide range of products, the scope for progression and variety of career pathways is incredibly broad. It's the job of these professionals to provide expert scientific knowledge and strategic advice to ensure that all products comply with the relevant, up-to-date legislation within their market. Common daily duties and responsibilities that you may manage within this role include:
keeping updated on national and international legislation, guidelines and practices
ensuring that you develop products that adhere to local regulations
providing expert advice to other scientists and manufacturers
liaising and negotiating with regulatory authorities to obtain market approval for new products
collating a wide range of scientific data from various sources in relation to the company's products
presenting clearly defined arguments to obtain licence variations and renewals within strict deadlines
creating clear and easy-to-read product labels and information leaflets
reviewing organisational practice and introducing changes where necessary
developing product trials to collect and analyse product data
How much do regulatory affair professionals earn?
This career path can be very financially rewarding, and as your career develops, the earning potential can greatly increase. The national average salary of a regulatory affairs manager is £53,393 per year. Depending on your geographical location, experience and the organisation you work for, your earnings can be much higher. Many industries rely on regulatory officers, from pharmaceuticals to cosmetics sectors, providing several career advancement opportunities in lucrative industries.
Related: Highest paying jobs in the UK
How to start a career in this sector
These professionals require a thorough education with a background in science, and it's important to gain essential experience within their chosen sector. It can take several years to gain the relevant knowledge and skills to qualify for a regulatory position. You can use the following steps to help you start a career in this industry:
1. Meet the university entry requirements
To start a career in this profession, it's imperative that you begin making preparations prior to applying for university. To ensure you qualify for your chosen university, you can check their specific entry requirements which are typically listed on their website. If you're unsure which university you want to attend, the following guide may help you to meet most universities' entry requirements for a life sciences degree:
Most universities offering a degree in life sciences require a minimum of five GCSE qualifications at grade C or above, including maths, English language and science.
It's also typical for entry to require three A-levels at grade B or above, including at least two core sciences (biology, chemistry and physics) and mathematics.
Some universities may also accept a BTEC level 3 extended diploma with a combined grade of distinction, distinction, merit (DDM) in applied science or biomedical science.
Related: What is a bachelors degree?
2. Complete a relevant degree
The next step in your education is to complete a relevant honours degree that provides you with the necessary knowledge to enter into this sector. Typical subject choices include a range of sciences, such as life, mathematical, applied and medical. Job candidates who have studied the following subject areas are likely to have several career opportunities:
If you have not completed a degree in one of these subject areas, earning a certification can help you become a more competitive candidate. It's also possible to enter into the profession as a regulatory administrator without obtaining a degree first, but your scope for progression can be greatly increased by continuing with your higher education.
3. Further your education
You can then further your education to develop your expertise in this field. You may consider studying for a Master of Regulatory Science degree and specialising in pharmaceuticals or devices to enhance your competency prior to applying for a regulatory role. Although obtaining a masters degree is not strictly necessary to enter into this sector, it's advantageous and can make you a more employable candidate.
Some companies also offer an apprenticeship programme specifically relating to this sector. These programmes typically last around 30 months and offer a combination of masters-level study, hands-on training and paid work experience. It's common for these placements to be filled internally, so you may try to gain a related role within the industry and then progress onto an available course.
4. Gain relevant work experience
Most regulatory positions, including entry-level roles, require candidates who have previous experience within that organisation's specific industry. A great way to gain regulatory experience is to complete an internship with a company in your desired field. You might also consider looking at the opportunities your university has to offer, such as placement years or graduate development schemes.
Taking on a research position or starting out your career within a product development, pharmaceutical development or formulation role is another great way to gain the necessary experience to enter into this profession. Working your way up the hierarchy within an organisation can provide you with essential regulatory framework knowledge and technical understanding of both the products and regulations within your chosen industry. Enhancing your knowledge of the following subject areas can also be beneficial:
relevant legal requirements legislation
manufacturing processes and techniques
pharmaceuticals and toxicology
IT and computer processing
medical devices and advancements
5. Continuous professional development
Working in this profession requires continuous professional development to ensure that you stay current with the constantly changing regulations and legislation in your region and around the world. Both new graduates and seasoned professionals are expected to undertake regular training courses to ensure that their knowledge remains current throughout their careers. This may range from one day of in-person training or completing online modules on relevant topics.
What skills can regulatory professionals develop?
To become successful in this profession and find an exciting new role, it's important to develop the necessary hard and soft skills that employers are looking for in job candidates. If working on products that are distributed internationally, fluency in one or more other languages can be greatly advantageous. Other skills that are sought after in regulatory professionals include:
precision and attention to detail
the ability to problem-solve and analyse large quantities of data
a strong understanding of both legal and scientific subject areas
clear written and verbal communication skills
confidence in negotiation tactics and delivering presentations
the ability to think clearly under pressure and adhere to strict deadlines
teamwork, leadership and project management skills
IT skills and working knowledge of commercial software
As these professionals require extensive knowledge of their chosen field, it can take time to work your way into a senior or specialist position during the early stages of your career. Prior to stepping into a senior position, such as head of affairs or associate director, you may be able to get a team leader or lower-level management role. It's also becoming increasingly common for companies to contract out regulatory services, so the scope for freelance and consultancy work is greatly increasing for more experienced professionals.
You can find regulatory positions across a whole range of sectors. There is typically work available across a range of industries for companies who develop and manufacture products such as:
food and nutrition products
cosmetics and beauty products
medical equipment and devices
homoeopathic and herbal remedy products
veterinary products and drugs
agrochemicals such as pesticides and fertilisers
Salary figures reflect data listed on Indeed Salaries at the time of writing. Salaries may vary depending on the hiring organisation and a candidate's experience, academic background and location.
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