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, chemicals, pesticides, therapeutic devices and other products.
Regulatory affairs officers are the crucial link between their company, its products and regulatory authorities, including the Medicines and Healthcare products Regulatory Agency (MHRA) , the US Food and Drug Administration (FDA) and the European Medicines Agency .
Typical work activities include:
Relevant degree areas include physical, mathematical, applied, medical and life 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.
Research experience is valuable, as is knowledge of:
Candidates will need to show evidence of the following:
Fluency in another European language, ideally French, Spanish or German, can be a distinct advantage and may increase promotion opportunities later on in a career, as companies increasingly operate in an international arena.
Competition is strong for new graduate vacancies, although opportunities have increased. There is a strong demand for people with prior experience in regulatory affairs. Recruitment levels vary, so it is advisable to make speculative applications to chemical and pharmaceutical companies.
Most staff enter the role after gaining experience in other relevant areas, such as research or quality assurance. Others progress from working as regulatory affairs assistants to more senior roles.
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 a diploma and MSc in Regulatory Affairs (for those with a minimum of approximately two years’ experience), validated by the University of Wales, and a diploma and MSc in Medical Technology Regulatory Affairs at Cranfield University. The courses, which are part-time, are aimed to meet the needs of professionals working in the field of regulatory affairs in the pharmaceutical and related industries.
Students must first complete the diploma course and then add a research-based dissertation to qualify for the MSc. Some stand-alone modules can also be studied for continuing professional development (CPD). Study at this level is becoming an important asset for progression, but as yet it is not a formal professional requirement.
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 programme. This offers one-day workshops covering areas such as:
TOPRA also offers CPD opportunities through e-learning and there are currently modules in negotiation and project management. New modules in leadership and managing high performance teams will be available soon.
In-house training opportunities vary between employers; some professionals may receive training and support from a more experienced colleague.
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, including the Medicines and Healthcare products Regulatory Agency (MHRA) .
With experience, it is possible to develop your career in more specialist areas.
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 can take time to progress in the early stages due to the demand for a range of skills and experience. However, further on, it is possible to move on relatively quickly into a senior role, which might be as a regulatory operations team leader, or unit manager.
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.
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 100 companies in the UK producing prescription medicines. Its member companies research, develop, manufacture and supply approximately 75% of the medicines prescribed through the National Health Service (NHS). The ABPI Careers website includes a comprehensive list of career opportunities in the industry and a section on regulatory affairs.
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 .
The European Medicines Agency offers about 40 traineeships per year, with an intake in October (apply in June). See the website for details.
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