Regulatory affairs officer
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 wide range of companies, meet the required legislation.
They advise on and coordinate the approval and registration of pharmaceuticals, veterinary medicines, complementary medicines, agrochemicals, pesticides, therapeutic devices, cosmetics and other products.
Regulatory affairs officers are the crucial link between their company, its products and regulatory authorities, including the:
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 beginning. Typical activities include:
Relevant degree areas include life, physical, mathematical, applied and medical sciences. In particular, the following subjects may increase your chances:
Newer life science subjects, such as biotechnology, may also be advantageous.
Entry is not possible with an HND/foundation degree only. A good honours degree is the minimum requirement. Although not essential, it may be an advantage if you have a PhD. It may also be useful to hold a legal qualification.
A professional qualification is also valued by employers. The Organisation for Professionals in Regulatory Affairs (TOPRA) offers an MSc in Regulatory Affairs. Approximately half of TOPRA members hold a postgraduate qualification.
New entrants to the role often have experience in other relevant areas, such as research or quality assurance, or with the Medicines and Healthcare products Regulatory Agency (MHRA) .
Research experience is valuable, as is knowledge of:
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.
Candidates will need to show evidence of the following:
Fluency in another European language, ideally French, Spanish or German, can be useful and may increase promotion opportunities later on in a career, as companies increasingly operate in an international arena.
When applying for roles it is important to have a thorough understanding of regulatory affairs and how drug development works. TOPRA runs an online Basics of Regulatory Affairs course aimed at those interested in gaining an understanding of regulatory affairs work.
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 a relevant professional body, such as TOPRA, provides evidence of your commitment to the career and provides networking opportunities. Read the specialist press, such as The Pharmaceutical Journal (see PJ Online ) and Regulatory Rapporteur (monthly journal of TOPRA), to keep up to date with industry news and issues.
For more information, see work experience and internships and search courses and research.
Professional training is available through The Organisation for Professionals in Regulatory Affairs (TOPRA) , including an MSc in Regulatory Affairs. This part-time course is aimed at those with some experience in the field of regulatory affairs.
Cranfield University also offers a part-time MSc Medical Technology Regulatory Affairs (also available at PgCert and PgDip level) in collaboration with TOPRA. The course is designed to fit around work commitments and is aimed at professionals working in healthcare regulatory affairs or related areas.
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 CRED (Continuing Regulatory Education and Development) programme. This offers one-day workshops covering areas such as:
It is also important to read the specialist press, such as The Pharmaceutical Journal (see PJ Online ), InPharm and Regulatory Rapporteur (monthly journal of TOPRA), to keep up to date with industry news and issues.
In-house training opportunities vary depending on the 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 Medicines and Healthcare products Regulatory Agency (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. The Organisation for Professionals in Regulatory Affairs (TOPRA) provides a careers coaching service, which is free to members and available on a fee basis to non-members, as well as a range of career development planning (CDP) opportunities.
However, further on, it is possible to move on 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 are increasingly being recruited to boardroom positions within companies.
One route to gaining promotion and wider experience of regulatory affairs is to 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.
Typical employers include companies that develop and manufacture:
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 association for around 150 companies in the UK producing prescription medicines. 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 Medicines and Healthcare products Regulatory Agency (MHRA) , an executive agency of the Department of Health (DH) with responsibility for the protection of public health through the regulation of human medicines, also employs staff in regulatory affairs, as does the European Medicines Agency .
Specialist recruitment agencies with an interest in regulatory affairs advertise vacancies. See the TOPRA website for a list.
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