If you have a scientific background, an interest in the law and excellent time management and communication skills, consider a career in regulatory affairs
As a regulatory affairs officer, you'll ensure the appropriate licensing, marketing and legal compliance of a range of pharmaceutical and medical products in order to control their safety and efficacy. Products include:
- veterinary medicines
- complementary medicines
- therapeutic devices
You're the crucial link between your company, its products and regulatory authorities, and will combine your knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by a range of companies, meet the required legislation.
It can take up to 15 years to develop and launch a new pharmaceutical product and you'll be involved throughout the process, right from the start.
As a regulatory affairs officer, you'll need to:
- ensure that a company's products comply with the regulations of the regions where they want to distribute them
- keep up to date with national and international legislation, guidelines and customer practices
- collect, collate and evaluate scientific data from a range of sources
- develop and write clear arguments and explanations for new product licences and licence renewals
- prepare submissions of licence variations and renewals to strict deadlines
- monitor and set timelines for licence variations and renewal approvals
- work with specialist computer software and resources
- write clear, accessible product labels and patient information leaflets
- plan and develop product trials and interpret trial data
- advise scientists and manufacturers on regulatory requirements
- provide strategic advice to senior management throughout the development of a new product
- project manage teams of colleagues involved with the development of new products
- undertake and manage regulatory inspections
- review company practices and provide advice on changes to systems
- liaise with, and make presentations to, regulatory authorities
- negotiate with regulatory authorities for marketing authorisation
- specify storage, labelling and packaging requirements.
- Starting salaries for those with one to two years experience range from around £20,000 to £30,000.
- Salaries for specialist or experienced regulatory affairs professionals (three to five years' experience) typically range from £30,000 to £50,000. Managers can earn in the region of £50,000 to £70,000.
- Salaries for those with extensive experience, for example at associate director or director level, can rise to in excess £100,000.
Salaries vary according to the type of employer, location, your qualifications and experience. Some employers provide bonus payments and additional benefits, such as a pension, company car or private healthcare.
Income figures are intended as a guide only.
Working hours can include regular extra hours to meet tight deadlines, but not weekends or shifts. There are also some opportunities for part-time work.
What to expect
- This is a desk-based role, involving the close study of scientific and legal documents. You'll also work closely with scientific and medical colleagues, often on a project-team basis. Larger companies often have a regulatory affairs department, while smaller companies may employ only one or two specialist staff.
- Although there's a concentration of healthcare companies in London and the South East, the M4 corridor and Cambridge areas, small start-up and device companies are more evenly spread throughout the UK.
- With experience it's possible to move into self-employment or freelance work through agencies.
- The role can be challenging as you'll need to meet tight deadlines and be able to negotiate successfully as an arbitrator, but can be rewarding when you see a new product successfully registered.
- If you work for an EU or US-based company, you may spend some time working abroad.
A good honours degree is usually the minimum requirement to work as a regulatory affairs officer. Relevant degree areas include life, physical, mathematical, applied and medical sciences. In particular, the following subjects may increase your chances:
- biomedical science
- chemical and physical sciences
- life sciences
You may need to take another role in the drug development process first in order to break into the regulatory affairs profession. You may also be able to gain entry via a related job, which could provide a useful background in drug development, for example research or quality assurance.
When applying for roles, make sure you have a thorough understanding of regulatory affairs and how drug development works. TOPRA (The Organisation for Professionals in Regulatory Affairs) runs a one-day Basics of Regulatory Affairs course (also available online) for those interested in a career in regulatory affairs.
Make sure you emphasise any relevant skills you have that can be used in regulatory affairs work, even if you've developed them in a different area of work.
You'll need to have:
- understanding of both legal and scientific matters
- the ability to grasp new concepts quickly and to assimilate and evaluate scientific data
- analytical and problem-solving skills
- written and oral communication skills
- attention to detail
- strong negotiation skills
- IT skills, particularly in relation to using databases and familiarity with commercial software
- the ability to work under pressure and to strict deadlines
- the confidence to report to management
- team-working skills and the ability to lead and motivate others
- project-management skills
- integrity and a professional approach to work
- tact and diplomacy
- an awareness of the legislation governing the approval of products.
Fluency in other European languages such as French, Spanish or German can also be useful.
Having research experience is valuable, as is knowledge of:
- clinical work
- manufacturing techniques
- relevant aspects of the law.
Large pharmaceutical companies may offer short fixed-term contracts in a specific area of regulatory affairs. Work experience or an internship in the pharmaceutical industry can be useful and provides an insight into the industry as a whole.
Student membership of TOPRA, which has a Young Regulatory Professionals group, shows your commitment to the profession and provides you with valuable networking opportunities.
Although relevant experience is usually required, some companies, such as contract research organisations and consultancies, may be willing to take on exceptional individuals with relevant skills and invest in their training.
Typical employers include companies that develop and manufacture:
- food/nutritional products
- herbal and homeopathic products
- medical devices
- veterinary products.
The Association of the British Pharmaceutical Industry (ABPI) represents biopharmaceutical companies that supply more than 80% of all branded medicines used by the NHS. See their website for a list of member companies.
Other organisations that employ regulatory affairs professionals include:
- contract research organisations that undertake research trials for companies
- Medicines and Healthcare products Regulatory Agency (MHRA)
- European Medicines Agency - offers a number of traineeships annually aimed at graduates at the beginning of their careers.
Look for job vacancies at:
Some specialist pharmaceutical recruitment agencies advertise vacancies. It's also worth making targeted speculative applications to chemical and pharmaceutical companies.
In-house training opportunities vary depending on your employer and you may receive training and support from a more experienced colleague.
Professional training is available through TOPRA, which offers a range of courses at postgraduate level:
- Postgraduate Certificate
- Postgraduate Diploma Regulatory Affairs - Medicines or Medical Devices
- MSc Regulatory Affairs - Medicine or Medical Devices.
Find out more at TOPRA - Qualifications.
Courses are validated by the University of Hertfordshire and are designed to fit around work commitments. They also offer a full or part-time PhD in regulatory affairs if you'd like to develop your career in research.
Membership of TOPRA is useful for keeping up-to-date with developments in scientific research and provides a range of networking and continuing professional development (CPD) opportunities through events, courses and conferences.
If you're qualified to at least first degree level in a relevant subject, have at least two years' full-time experience as a healthcare regulatory professional and are engaging in CPD to keep your skills and knowledge up to date, you can apply to become a registered member of TOPRA and use the designation MTOPRA.
It can take time to progress in the early stages of your career due to the demand for a range of skills and experience. However, further on, it's possible to move relatively quickly into a more senior role, progressing to regulatory operations team leader, unit manager or head of regulatory affairs.
With the right combination of skills and experience, it's possible to influence decisions at the highest level, and senior regulatory affairs professionals can be recruited to boardroom positions within companies.
There's a growing trend for companies to contract out regulatory and related specialist services, giving increasing opportunities for progression into consultancy for experienced professionals.
Alternatively, you could develop your career into a more specialist area or move into research.