Regulatory affairs officer | Prospects.ac.uk

As a regulatory affairs officer, you'll act as a key link between your company, its products and regulatory authorities. You'll use your understanding of science, alongside legal and business awareness, to ensure that the medicines and medical devices your company develops, manufactures or supplies are fit for purpose and comply with relevant legislation and guidance.

Products can include:

pharmaceuticals
vaccines
veterinary medicines
combination products (such as insulin pens and inhalers)
therapeutic devices
in vitro diagnostic devices (IVDs)
complementary medicines
agrochemicals and pesticides
cosmetics.

It can take 10 to 15 years to develop and launch a new pharmaceutical product, and you may be involved throughout the process, from early development, including clinical trial authorisations (CTAs), through to post-market surveillance and post-launch compliance.

Responsibilities

As a regulatory affairs officer, you'll need to:

ensure products meet UK and international regulatory requirements for the markets where they will be supplied
keep up to date with relevant legislation, regulatory guidance and regulator expectations, including from the Medicines and Healthcare products Regulatory Agency (MHRA) and other global authorities
help shape regulatory strategy and advise senior stakeholders on the best route to approval and ongoing compliance
gather, collate and critically evaluate scientific and technical data to support regulatory submissions
prepare and submit applications for marketing authorisations (product licences), responding to questions from regulators and contributing to negotiations where needed
prepare and submit variations and renewals to agreed quality standards and deadlines
ensure regulatory records and documentation are clear, accurate and up to date
manage regulatory timelines and coordinate input from departments such as research and development (R&D), clinical, quality and manufacturing
write, review and approve product information (for example, labelling and patient information leaflets)
coordinate meetings and correspondence with regulatory authorities, and communicate requirements and decisions internally
review and approve packaging and promotional materials to ensure they comply with relevant legislation and codes.

Salary

Early-career salaries are typically between £30,000 and £45,000.
Salaries for experienced regulatory affairs professionals range from £45,000 to £85,000, depending on the role.
Salaries for those with extensive experience, for example at associate director or director level, can range from £80,000 to £160,000.

Salaries vary according to the size and type of employer, location, your qualifications, experience and level of responsibility.

In addition to a company pension, some employers provide benefits such as bonus payments, a car allowance or private healthcare.

Figures are intended as a guide only.

Working hours

Working hours are usually regular office hours, but you may need to work extra hours at busy times (for example, to meet submission deadlines). Weekend or shift working isn't typical, though occasional out-of-hours work may be needed.

Part-time work and opportunities for hybrid working may be available.

What to expect

The role is desk based and involves close study of scientific and legal/technical documents. You'll work closely with colleagues in R&D, clinical, medical, quality and manufacturing, often in project teams.
Larger companies often have a regulatory affairs department, while smaller companies may employ only one or two specialist staff.
Roles are commonly found in major UK life-sciences clusters, particularly London, Oxford, Cambridge and the M4 corridor, as well as other UK hubs and start-ups.
With experience, some people move into consultancy or freelance regulatory work through consultancies, contracting or direct clients.
The role can be challenging as you'll need to meet tight deadlines and be able to influence and negotiate with internal stakeholders and regulators. It can also be rewarding when you see a new product approved, authorised and on the market.

Qualifications

You'll usually need at least a good honours degree to work as a regulatory affairs officer. Relevant degree subjects include:

life and medical sciences (for example, biomedical science or biotechnology)
chemistry and related physical sciences
pharmacy and pharmacology
engineering (particularly for medical devices).

You may need to start in another role first to build relevant experience. Useful entry routes can include quality assurance, clinical research, research and development (R&D) or regulatory operations (for example, submissions support).

When applying for jobs, make sure you understand what regulatory affairs involves and how the development and approval process works. Highlight any relevant skills you have, such as clear writing, attention to detail, analysing complex information and working to deadlines, even if you've developed them in a different area of work.

TOPRA (The Organisation for Professionals in Regulatory Affairs) runs one-day Basics of Regulatory Affairs courses (also available online) in pharmaceutical, veterinary and medical device regulatory affairs. It also offers longer introductory courses for people new to the profession.

Although you don't need a Masters degree to begin a career in regulatory affairs, TOPRA offers postgraduate qualifications validated by the University of Hertfordshire, including:

Postgraduate Certificate Regulatory Affairs
Postgraduate Diploma Regulatory Affairs (Medicines or Medical Devices)
MSc Regulatory Affairs (Medicines or Medical Devices).

You can also enter the profession via a Masters-level (Level 7) regulatory affairs apprenticeship. To get a place, you must be employed in a role that provides suitable regulatory experience and have an employer who will support your training. You'll usually need an undergraduate degree or equivalent in science or engineering. Apprenticeships combine paid work with part-time study, allowing you to train on the job.

Skills

You'll need to have:

an understanding of both scientific and legal/regulatory requirements
the ability to analyse complex technical information and evaluate evidence
problem-solving skills and the ability to adapt and be flexible
excellent written communication skills, with attention to detail
confident verbal communication, including negotiation skills, to explain decisions and influence stakeholders
strong organisation and record-keeping skills
the ability to work well under pressure and to strict deadlines, while prioritising competing tasks
teamwork and leadership skills with the ability to build effective working relationships across departments
project management skills
IT skills, including using databases and document management systems
integrity and a professional approach to work.

Knowledge of other European languages such as French, Spanish or German can be useful.

Work experience

It's useful to get research experience while at university. This could be through dissertation projects, research placements or research assistant roles, for example. Internships or placements in related areas, such as clinical research, quality or laboratory teams, are also helpful.

Experience in the pharmaceutical or medical device industry can provide an insight into how regulated products are developed and maintained. Some large employers also offer short fixed-term contracts or entry-level roles in regulatory affairs or regulatory operations (such as submissions support).

Experience in pharmacovigilance/safety, pharmacy, data management or technical/medical writing can also be a good route into the profession.

Joining TOPRA as a student can help you build your knowledge and professional network.

Any experience that develops your communication and project management skills, as well as your ability to summarise and interpret complex information, is useful.

Find out more about the different kinds of work experience and internships that are available.

Employers

Typical employers include companies that develop, manufacture or supply regulated products such as:

pharmaceuticals and biotechnology products
medical devices and diagnostics
veterinary medicines
herbal and complementary medicines agrochemicals and pesticides
cosmetics and personal care products
food and nutritional products (including supplements).

Other organisations that employ regulatory affairs professionals include:

service providers such as consultancies, contract research organisations (CROs) and other specialist regulatory service companies
regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) and international agencies such as the European Medicines Agency
notified bodies, which assess the conformity of medical devices before they're placed on the market.

Look for job vacancies at:

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

You could also make targeted speculative applications to pharmaceutical and medical device companies. The Association of the British Pharmaceutical Industry (ABPI) represents large, small and medium-sized companies who invest in discovering new medicines. See their website for a list of member companies.

Search for apprenticeship positions on TOPRA Jobs and on employers' websites.

Professional development

In-house training opportunities vary depending on your employer, and you'll often learn on the job with support from more experienced colleagues.

TOPRA offers professional development opportunities through short courses, events and conferences, helping you keep up to date and build a professional network. They also provide postgraduate qualifications, validated by the University of Hertfordshire, including a PhD route for those interested in regulatory affairs research. Find out more at TOPRA - Qualifications.

With experience, you can apply to become a TOPRA Registered Member and use the designation MTOPRA. Eligibility includes a relevant degree (or equivalent), at least two years' full-time experience practising as a healthcare regulatory professional, and evidence of ongoing CPD.

You may also be able to apply for professional registration as a Registered Scientist (RSci) or Chartered Scientist (CSci), depending on your qualifications and experience.

Career prospects

You'll typically start in an entry-level role such as regulatory affairs assistant, associate or officer, learning the basics and helping with document preparation and submissions. As you build experience across scientific evidence, legislation and regulatory processes, you can progress into roles with more responsibility for your own products or projects, often as a senior associate or regulatory affairs executive.

With further experience, you may move into senior and specialist posts (for example, regulatory strategy, labelling or regulatory operations) or into people-management roles leading teams and overseeing regulatory plans and timelines. At senior level, you could progress to head of regulatory affairs, associate director or director, with responsibility for strategy and relationships with regulators.

Experienced regulatory professionals may also move into consultancy or contract work, as many organisations use external regulatory expertise.

TOPRA has more information on career progression.