Regulatory affairs officer

Regulatory affairs officers ensure the appropriate licensing, marketing and legal compliance of a range of pharmaceutical and medical products in order to control their safety and efficacy

As a regulatory affairs officer, you'll be the crucial link between your company, its products and regulatory authorities. You'll combine your knowledge of scientific, legal and business issues to ensure that the medical and pharmaceutical products a company develops, manufactures or distributes, meet the required legislation and are fit for purpose.

Products include:

• pharmaceuticals
• veterinary medicines
• complementary medicines
• agrochemicals
• pesticides
• therapeutic devices
• diagnostic devices
• cosmetics.

It can take 10 to 15 years to develop and launch a new pharmaceutical product and you'll be involved throughout the process, right from the start.

Responsibilities

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
• respond to queries from medical bodies like the Medicines and Healthcare products Regulatory Agency (MHRA)
• 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
• oversee product trials and interpret trail data
• 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
• take part in the development of marketing concepts and approve packaging and advertising before a product's release.

Salary

• Starting salaries for those with one to two years' experience range from around £30,000 to £40,000.
• Salaries for specialist or experienced regulatory affairs professionals (three to five years' experience) typically range from £40,000 to £60,000. Managers can earn in the region of £60,000 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.

Figures are intended as a guide only.

Working hours

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 desk-based role involves the close study of scientific and legal documents. You'll 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.
• There's a concentration of healthcare companies in London and the South East, the M4 corridor and Cambridge areas. However, 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. It can also be rewarding when you see a new product successfully registered.
• You may spend some time working abroad if you work for an EU or US-based company.

Qualifications

You'll usually need at least a good honours degree 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:

• biochemistry
• biology
• biomedical engineering
• biomedical science
• biotechnology
• chemical and physical sciences
• chemistry
• epidemiology
• engineering
• medicine
• pharmacology
• pharmacy.

A Masters degree isn’t essential for a career in regulatory affairs, but if you're looking to study at this level, TOPRA (The Organisation for Professionals in Regulatory Affairs) runs two courses: The MSc Regulatory Affairs (Medicines) and the MSC Regulatory Affairs (Medical Devices) offered by the University of Hertfordshire.

You may have to take another role in the drug or device development process first, in order to break into regulatory affairs. You could also start in a related job, for example, research or quality assurance, which could provide a useful background in drug development.

You can also get into the profession via a regulatory affairs apprenticeship. You'll usually need an undergraduate degree or equivalent in science, engineering or sometimes law to apply. Check with employers for exact entry requirements.

The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience. Many employers recruit apprentices internally so you could try getting into the pharmaceutical or medical device industry first and then moving sideways.

Make sure you have a thorough understanding of regulatory affairs and how drug development works when applying for jobs. You must 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.

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.

Skills

You'll need to have:

• an understanding of both legal and scientific matters
• the ability to take in complex technical information and make sense of it
• 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
• teamworking skills and the ability to lead and motivate others
• project-management skills
• good time management
• integrity and a professional approach to work.

Fluency in other European languages such as French, Spanish or German can also be useful.

Work experience

Having research experience is valuable, as is knowledge of:

• clinical work
• toxicology
• pharmaceuticals
• medical devices
• 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.

Joining TOPRA as a student will enable you to build your knowledge and networks. It is available for students in full-time undergraduate students in any degree course.

Employers

Typical employers include companies that develop and manufacture:

• agrochemicals
• biotechnology
• cosmetics
• food and nutritional products
• herbal and homeopathic products
• medical devices
• pharmaceuticals
• veterinary products.

The Association of the British Pharmaceutical Industry (ABPI) represents biopharmaceutical companies that supply more than 80% of the value 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 and consultancies that undertake research trials for companies
• Medicines and Healthcare products Regulatory Agency (MHRA)
• European Medicines Agency - offers traineeships annually aimed at graduates at the beginning of their careers.

Look for job vacancies at:

• emedcareers
• New Scientist Jobs
• PharmiWeb
• TOPRA Jobs

Specialist pharmaceutical recruitment agencies, such as Proclinical, also advertise vacancies.

You could also make targeted speculative applications to chemical and pharmaceutical companies.

Search for apprenticeship positions on TOPRA Jobs or on the websites of regulatory affairs employers.

Professional development

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 - Medicines or Medical Devices.

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. Find out more at TOPRA - Qualifications.

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.

You can apply to become a registered member of TOPRA and use the designation MTOPRA if:

• you're qualified to at least first degree level in a relevant subject
• you have at least two years' full-time experience as a healthcare regulatory professional and are currently practicing
• you're engaging in CPD to keep your skills and knowledge up to date.

Professional registration as either a registered or chartered scientist is open to regulatory affairs professionals with the right combination of knowledge, understanding and competence.

Career prospects

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 as long as you can show you have the required level of competency.

There are opportunities to progress into senior and specialist regulatory affairs roles before developing your career further into roles such as regulatory operations team leader and unit manager. The most senior roles are at head of regulatory affairs, associate director and director level when you'll have responsibility for teams of regulatory staff and overall strategy.

It's currently rare to move into a boardroom position, where you'll have the opportunity to influence decisions at the highest level, although this may change in the future.

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. The transferable skills gained as a regulatory affairs officer also give you options for working in other areas of business such as in quality assurance.