Careers

Why should you consider a career in Regulatory Affairs?

A guide to those thinking about moving into Regulatory Affairs, prepared by TOPRA – The Organisation for Professionals in Regulatory Affairs.

• Do you want to work in a business sector that can influence the health and well-being of millions of people?
• Do you want to be able to constantly extend your scientific and legal knowledge?
• Do you want to work with intelligent, driven colleagues on projects that challenge your thinking and allow you to stretch yourself?
• Do you want to exercise personal skills in a role that has exciting career opportunities to the highest level?

If the answer to all these questions is ‘yes’ then healthcare Regulatory Affairs could be the career for you!

How do I get into the profession?

The number of regulatory positions open to those with no experience is rather limited. Here are a few hints to
help you:

• If you have no experience, but can demonstrate that an aspect of your education, research or work experience has particular relevance to general regulatory work, or to the therapeutic area that the potential employer has products in, you will have an advantage.
• Some companies and especially Contract Research Organisations (CROs) will take on talented individuals and invest in their training.
• The mainstream pharmaceutical companies may offer short fixed-term contracts in one area of the regulatory process (e.g. preclinical summary writing) to allow an individual to get limited experience, before considering them for a permanent position.
• Strive to demonstrate that you have some of the technical and personal skills needed by a good regulatory person. The ability to deal with a range of scientific disciplines, negotiation skills, team-working skills, the ability to work under pressure to an agreed deadline, good verbal communication and the ability to write clearly and summarise data effectively are all
  important. If you have experience which shows these skills, emphasise them in your CV.
• Try to become familiar with current regulatory issues. Knowledge of the basic regulatory processes can be gained from textbooks which should be held in the pharmacy section of your library. The current issues are written about in pharmaceutical journals such as ‘Scrip’, (also available on-line), and the Pharmaceutical Journal. The TOPRA journal, Regulatory Rapporteur, would keep you up-to-date and you could receive this by applying to be a Member.
• Membership of TOPRA is a cost-effective way to show a commitment to your choice of career and to meet colleagues and contacts that could help you in the future.
• Job opportunities in this field are advertised either in general journals, such as New Scientist, or more frequently in Regulatory Rapporteur and on the TOPRA website at www.topra.org/careers/job-shop
• There are specialist recruitment consultants in the pharmaceutical field, some of whom have a particular interest in Regulatory Affairs. You can enrol with them and they will give you advice and put you forward for suitable positions. There is a list on the TOPRA website www.topra.org.
• You could write to Human Resource departments of pharmaceutical companies in your preferred part of the country to see if they are likely to be recruiting in the near future. They may have positions in other disciplines in the company which would give you background knowledge of drug development, which would prove useful in a subsequent regulatory career.
• TOPRA offers a career coaching service, with a free initial consultation for TOPRA members. See the website for more details. Regulatory Affairs is challenging, exciting and a growing profession – why not join it?

Lifelong Learning (LLL) is a tool for RA professionals at all stages of their careers, from new entrants to the profession through to senior level staff. To find out more about LLL and the necessary Key Regulatory and Professional Competences please visit www.topra.org/lifelonglearning.