Careers information pack

Welcome to the Regulatory Affairs Careers Information Pack, compiled by the New Regulatory Professionals SPIN Group. If you are interested in starting a career in regulatory affairs, be it as a graduate or someone working in an allied field looking for a change, this online pack has been developed with you in mind.

What is regulatory affairs?

Interview photoRegulatory Affairs is a function within healthcare organisations. It serves as the interface between companies and the health authorities who are responsible for licensing their product(s). Companies can be primarily focused on developing pharmaceuticals, vaccines, medical devices, in vitro diagnostics (IVDs) and combination products; as well as the maintenance and safe use of such products throughout their lifecycles.

Regulatory professionals play a pivotal role in licensing market medicinal products, via marketing authorisations (MAs). A whole host of regulatory roles coordinate to bring new safe and effective medicines to patients. From obtaining the initial clinical trial authorisations (CTAs) to post-market surveillance and lifecycle maintenance, regulatory professionals are responsible for meeting the requirements of national governments and regional agencies, eg EMA, for the safety and efficacy of healthcare medicinal products, medical devices and veterinary medicines. These professionals keep track of the ever-changing legislation in all the regions in which a healthcare company wishes to distribute its products, advise on the legal and scientific requirements, and collect, collate and evaluate scientific data.

 Top tip: Read our Glossary of Terms for an explanation of any acronyms you aren't familiar with.

Employers

Regulatory affairs professionals generally work in three types of organisation:

  • Industry, eg pharmaceutical or biotech companies
  • Regulators, spanning individual national agencies and competent authorities to international bodies such as the US FDA or EMA
  • Service providers, including clinical research organisations (CROs), consultancies, technology developers and service providers.

Regulatory roles vary depending on the type and size of the organisation. For example, a large pharmaceutical company has multiple departments specialising in specific areas. SMEs and many CROs tend to be much smaller with more opportunities to get involved in all aspects of the regulatory function.

(See the 'Roles' tab for more detailed information on different types of role in industry.)

National agencies/competent authorities

Each EU member state (MS), and partner countries such as Switzerland, has a competent authority (CA). The CA is a government body in each MS that that transposes the requirements of the EU legislation into national law and is responsible for ensuring regulatory compliance in its jurisdiction.

Many national agencies (NA)/CAs offer graduate programmes or contract roles. Roles available in agencies may vary but include both technical (qualifications in medicine, pharmacy, veterinary medicine, biology, immunology, chemistry, engineering, etc) and non-technical (qualifications in law, information technology, accountancy, business, human resources and training, etc).

Notified bodies

A notified body (NB) is an organisation designated by an EU MS to assess the conformity of medical devices before being placed on the market. A conformity assessment is carried out to demonstrate the device meets legal requirements to ensure it is safe and performs as intended – once this is achieved manufacturers can apply a CE mark to the product.

NBs carry out tasks related to conformity assessment procedures as set out in the applicable legislation, when a third party is required. They recruit for a variety of roles including:

  • Quality system auditors
  • Microbiology auditors
  • Technical specialists
  • Clinical specialists
  • Project managers
  • Project coordinators
  • Client service coordinators.

For auditor and specialist roles, NBs usually require a university degree or equivalent qualification in relevant studies such as medicine, pharmacy, engineering or other relevant sciences. In addition, these roles usually specify at least four years’ experience in the field of healthcare products or related activities. A knowledge of relevant standards and legislation is also required.

 

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