Regulatory affairs officers ensure the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products, in order to control the safety and efficacy of products.
They combine their 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.
They advise on and coordinate the approval and registration of:
- veterinary medicines;
- complementary medicines;
- therapeutic devices;
- other products.
Regulatory affairs officers are the crucial link between their company, its products and regulatory authorities, including the:
- European Medicines Agency
- Medicines and Healthcare products Regulatory Agency (MHRA)
- US Food and Drug Administration (FDA)
It can take up to 15 years to develop and launch a new pharmaceutical product and a regulatory affairs officer will be involved throughout the process, right from the start. Typical activities include:
- ensuring that a company's products comply with the regulations of the MHRA;
- keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to;
- collecting, collating and evaluating scientific data that has been researched by colleagues;
- developing and writing clear arguments and explanations for new product licences and licence renewals;
- preparing submissions of licence variations and renewals to strict deadlines;
- monitoring and setting timelines for licence variations and renewal approvals;
- working with specialist computer software and resources;
- writing clear, accessible product labels and patient information leaflets;
- planning and developing product trials and interpreting trial data;
- advising scientists and manufacturers on regulatory requirements;
- providing strategic advice to senior management throughout the development of a new product;
- project managing teams of colleagues involved with the development of new products;
- undertaking and managing regulatory inspections;
- reviewing company practices and providing advice on changes to systems;
- liaising with, and making presentations to, regulatory authorities;
- negotiating with regulatory authorities for marketing authorisation;
- specifying storage, labelling and packaging requirements.
- Typical starting salaries range from around £20,000 to £27,000.
- Salaries for specialist or experienced regulatory affairs professionals range from £30,000 to £55,000, while senior managers can earn in the region of £60,000 to £80,000.
- Salaries for those with extensive experience, for example at associate director level, can rise to £100,000.
Salaries vary according to type of employer, location, 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. It also requires close working with scientific and medical personnel, often on a project-team basis.
- Regulatory affairs roles have considerably broadened in scope within the last few years and usually entail involvement throughout the lifecycle of a product.
- Work in larger companies is often in their regulatory affairs departments, while smaller companies may employ only one or two specialist staff.
- Self-employment is usually possible. Freelance work through agencies is possible with experience. There is a growing trend for companies to contract out regulatory and related specialist services, giving increasing opportunities for progression into consultancy for experienced professionals.
- Although there is 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.
- The gender split within the profession is fairly even with membership of The Organisation for Professionals in Regulatory Affairs (TOPRA) split 60% female and 40% male.
- The role can be challenging because of the need to maintain high levels of accuracy, meet tight deadlines and negotiate successfully as an arbitrator.
- Travel and absence from home overnight are common.
- Overseas travel is also common and usually increases with seniority of position. For individuals employed by an EU or US-based company particularly, there may be some periods of travel and work abroad.
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;
A good honours degree is usually the minimum requirement for entry into the profession.
Although not essential, it may be an advantage if you have a higher degree. Part-time MSc courses, such as the MSc in Regulatory Affairs offered by TOPRA, are available to professionals to help career development.
You may need to take another role in the drug development process in order to break into the regulatory affairs profession.
When applying for roles, make sure you have a thorough understanding of regulatory affairs and how drug development works. TOPRA runs a one-day Basics of Regulatory Affairs course (also available online) aimed at those interested in getting into the profession.
It is important to emphasise any relevant skills you have that can be used in regulatory affairs work, even if you have developed them in a different, or related, work area.
Recruitment levels vary, so it is advisable to make speculative applications to chemical and pharmaceutical companies. It may be possible to gain entry via a related job, which could provide a useful background in drug development and a subsequent move into regulatory affairs.
Student membership of TOPRA, which has a Young Regulatory Professionals Group, provides evidence of your commitment to the career and provides networking opportunities.
You will need to show evidence of the following:
- analytical and problem-solving skills;
- the ability to grasp new concepts quickly and to assimilate data from a range of scientific areas;
- written and oral communication skills;
- considerable understanding of both legal and scientific matters;
- attention to detail;
- 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;
- strong negotiation and arbitration skills;
- team-working skills and the ability to lead and motivate others;
- networking skills and the ability to get on with a variety of people;
- project-management skills;
- integrity and a professional approach to work;
- tact and diplomacy;
- an awareness of the legislation governing the approval of products (for EU legislation, see EudraLex).
Fluency in another European language, ideally French, Spanish or German, can be useful and may increase promotion opportunities later on in your career, as companies increasingly operate in an international arena.
New entrants to the role often have experience in other relevant areas, such as research or quality assurance.
Research experience is valuable, as is knowledge of:
- clinical work;
- manufacturing techniques;
- relevant aspects of the law.
Relevant experience is often required, although 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.
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.
Typical employers include companies that develop and manufacture:
- food/nutritional products;
- herbal and homeopathic products;
- medical devices;
- veterinary products.
Contract research organisations that undertake research trials for companies also employ regulatory affairs professionals.
The Association of the British Pharmaceutical Industry (ABPI) is the trade body that represents the research-based bio-pharmaceutical industry in the UK. Its member companies research, develop, manufacture and supply approximately 90% of the medicines prescribed through the National Health Service (NHS). See their website for a list of member companies.
The MHRA, an executive agency sponsored by the Department of Health (DH) with responsibility for the regulation of medicines, medical devices and blood components for transfusion in the UK, also employs staff in regulatory affairs, as does the European Medicines Agency.
Look for job vacancies at:
- European Medicines Agency - annually offers a number or traineeships aimed at graduates at the beginning of their careers.
- Medicines and Healthcare products Regulatory Agency (MHRA)
- New Scientist Jobs
- The Organisation for Professionals in Regulatory Affairs (TOPRA)
- The Pharmaceutical Journal
- Wiley Job Network - Pharmaceutical Jobs
- National and regional press.
- Company websites. For a list of UK research-based pharmaceutical companies, see the ABPI.
Some specialist pharmaceutical recruitment agencies advertise vacancies.
Professional training is available through TOPRA, which offers a part-time MSc Regulatory Affairs, validated by the University of Hertfordshire.
Cranfield University offers a part-time MSc Medical Technology Regulatory Affairs (also available at PgCert and PgDip level) in collaboration with TOPRA. You can also take individual modules as standalone short courses.
Both courses are designed to fit around work commitments and are aimed at professionals working in regulatory or medical regulatory affairs.
Membership of relevant professional bodies such as TOPRA can be useful for career development and networking opportunities.
Keeping up to date with developments in scientific research and development and regulatory matters is a key aspect of all regulatory affairs roles. As well as special events and conferences, TOPRA provides continuing professional development (CPD) opportunities through its Continuing Regulatory Education and Development (CRED programme. The programme comprises a series of one-day courses, run over a two-year cycle, in areas such as European regulatory procedures, clinical trials, patient information leaflet and labelling and generics medicine.
In-house training opportunities vary depending on your employer; some professionals may receive training and support from a more experienced colleague.
New entrants often have prior experience in other relevant areas, such as research or quality assurance, or with the MHRA. Others progress from working as regulatory affairs assistants to more senior roles.
Progression from a regulatory affairs assistant role to an officer's role is more likely within larger companies with a regulatory affairs department. However, not all companies with regulatory affairs departments are prepared to recruit and train graduates in this area; many prefer to employ experienced staff from other companies. There is, therefore, considerable movement of experienced staff between employers.
It can take time to progress in the early stages of your career due to the demand for a range of skills and experience. TOPRA provides members with access to a free careers coaching service, as well as a range of career development planning opportunities.
However, further on, it is possible to move relatively quickly into a senior role, which might be as a regulatory operations team leader, unit manager or head of regulatory affairs. With experience, it is possible to influence decisions at the highest level, and senior regulatory affairs professionals can be recruited to boardroom positions within companies.
To gain promotion and wider experience of you can move into consultancy after a period of post-degree work at a pharmaceutical company.
It is also possible, with experience, to develop your career in more specialist areas.