Regulatory affairs (RA), also known as government affairs, is a profession involved in monitoring and regulating the development, manufacture, testing and marketing of products from a range of industries.
There’s never been a better time to work in the field. Thanks to globalisation and the increasing demand for safe food and medicines, regulatory affairs jobs are in high demand. And with plenty of opportunities for travel, professional development and international employment, regulatory is a great career choice for anyone with a background in science.
But what does a career in regulatory affairs look like? To help your job search, we’ve put together this regulatory job profile.
What is a regulatory body?In simple terms, a regulatory body (also known as a regulatory agency or regulatory authority) is a public or government agency created to oversee specific industries and practices.
Regulatory bodies protect the public by providing and enforcing health and safety standards for organisations operating in . They differ to professional organisations because they are created on the basis of a legal mandate or legislation and have statutory authority to perform their functions. Regulatory bodies are one of the main regulatory affairs employers.
What are examples of regulatory agencies?
Examples of regulatory bodies related to science include:
- The Food and Drug Administration (FDA) — a US government body responsible for protecting public health by ensuring the safety, efficacy, and security of drugs
- The European Medicines Agency (EMA) — a European Union (EU) agency responsible for evaluating and supervising healthcare products
- The Medicines and Healthcare products Regulatory Agency (MHRA) — an executive agency of the UK government’s Department of Health and Social Care which ensures medicines and medical devices work and meet safety standards
- The Food Standards Agency — a non-ministerial government department responsible for protecting the public health in relation to food in England, Wales and Northern Ireland
- The Care Quality Commission (CQC) — an executive non-departmental public body of the UK government’s Department of Health and Social Care that regulates and inspects health and social care services in England
- The Engineering Council — the UK’s regulatory body for the engineering profession
Types of regulatory jobs
Common job titles related to the regulatory affairs sector include:
- Quality assurance consultant
- Regulatory affairs officer
- Regulatory affairs specialist
- Regulatory analyst
- Regulatory associate
- Regulatory consultant
- Regulatory strategist
What does a regulatory affairs specialist do?Regulatory affairs specialists assist in obtaining and maintaining government approval of products from regulated industries such as pharmaceuticals, medical devices, energy and banking.
Acting as a link between companies and regulatory bodies, they ensure that companies in these sectors adhere to appropriate licensing, marketing and legal compliance standards.
Work environmentProcess engineers spend the bulk of their time in an office environment, working on a full-time, 9-to-5 basis.
The duties and responsibilities of regulatory affairs specialists vary from company to company, and have expanded in recent years due to the globalisation of markets and constantly evolving regulations. Typical responsibilities of someone working in a regulatory affairs department include:
- Study scientific and legal documents pertaining to specific regulatory requirements
- Collect, organise, evaluate and interpret information from a number of sources
- Ensure compliance with regulations set by regulatory bodies such as MHRA
- Keep up to date with the latest regulatory legislation
- Plan and oversee product trials and regulatory inspections
- Offer regulatory advice to companies and scientists
Typical employers of regulatory affairs specialists
- Chemical manufacturers
- Medical device manufacturers
- Pesticides manufacturers
- Pharmaceuticals manufacturers
- Regulatory bodies such as MHRA
- Research organisations
How much do regulatory affairs specialists make?According to Payscale data, the average salary for a regulatory affairs specialist in the UK is £32,744. Most entry-level roles in clinical research range from around £30,000 to £40,000. Salaries for specialists or experienced regulatory affairs professionals typically range from £40,000 to £50,000, though it’s possible to earn upwards of £60,000 in certain roles.
Wages in regulatory affairs are highly competitive and depend on a number of variables, including job title, certification, level of experience, employer and location.
How do you become a regulatory affairs specialist?
The minimum requirement for entry-level regulatory positions is usually a graduate degree. People working in regulatory affairs come from a wide range of academic backgrounds, including public health, biology, clinical science, law, engineering, business, economics, and even some arts degrees.
Given that regulatory affairs is such a broad area, standing out from other candidates can help increase your employability. Gaining an advanced degree or PhD in a relevant field can also make you a more attractive proposition for employers — particularly if it relates to the core specialism or sector of the employer.
In a competitive job market, it’s also important to get as much experience as possible. Finding a regulatory affairs internship to supplement your studies is the most direct way to achieve this.
Skills and experience
As with most jobs in science, academic qualifications alone will not be enough if you are looking for a mid-to-senior-level role. Of course, requirements vary from business to business, but core regulatory affairs skills that can be applied across the board include:
- IT and numeracy skills
- Analytical and problem-solving skills
- Critical thinking
- Meticulous attention to detail
- Industry knowledge
- Commercial and business awareness
The road into regulation is not as rigid as other occupations. If, for example, you’re a project manager wanting to work in regulatory affairs, if you are armed with these transferable skills, an appropriate degree and experience in a relevant field, there’s a good chance of finding employment.
Indeed, the Regulatory Affairs Professional Society (RAPS) state that most professionals in regulatory affairs moved into the field after gaining experience in another industry.
Of those that came from another sector, the majority worked in fields closely related to regulation, such as clinical science, biology, research and development, quality assurance and quality control, pharmacology, and healthcare industries.