Why should you consider a career in Regulatory Affairs?

Working Regulatory Affairs is an enticing prospect for many entry level candidates. Indeed, your career can benefit greatly from pursuing a position in this area.

There are a variety of positions available within Regulatory Affairs – from highly technical roles which concentrate on a particular product type, to roles dealing with multiple product types from concept to lifecycle maintenance and line extensions.

Working within Regulatory Affairs will also enable you to become a member of a variety of different project teams which in turn will give you great exposure to many different functions within the company.  

Sound like your kind of career? Well read on…

So how can an entry level candidate get into Regulatory Affairs? 

As  a recruitment consultancy specialists in Regulatory Affairs recruitment,  CK Regulatory are always being asked for advice by entry level candidates to help them find their first position in Regulatory Affairs.

To help give these candidates the best possible advice, we have conducted a survey of the following types of Regulatory Affairs professionals asking them for their advice and here’s what we found…

Getting experience is the key

Getting relevant experience of any kind will help you quickly transition into Regulatory Affairs. Here are a few specific suggestions from our survey respondents:

• Try to gain relevant practical experience in pharmacy, manufacturing, toxicology, development, quality assurance or compliance. This will help you develop transferrable skills such as the ability to:
  • Manage multiple projects
  • Think logically and organise yourself well
  • Comply with the GxP standards

It is recommended that you work in these areas for at least one year before you try to make the move into Regulatory Affairs.

• If you are already working in one of the areas above, it’s a great idea to request to do some shadowing in the Regulatory Department.
• Be sure to gain an in-depth knowledge of the most commonly used processes in Regulatory Affairs (eCTD etc.)

Learn, learn learn…

By doing your research and improving your knowledge in this field, you will demonstrate your keen interest in Regulatory Affairs to prospective employers. How can you do this? Our survey recipients have given this advice:

• Read up on the subject – learn about the variations in guidelines, find out the differences between requirements for solid dose, steriles, creams, biologics etc.
• Think about joining TOPRA and try to read the Regulatory Rapporteur on a regular basis to keep up with the latest information.
• Complete the TOPRA Introductory course – European Regulatory Affairs to help increase your understanding of the area and become more attractive to employers.
• Contact your countries regulatory authority to help you keep up to date with any updated regulations.
• Perfect your knowledge of the MHRA, EMEA, and US-FDA guidelines.
• Use the internet and read relevant text to help you learn as much as you can about Regulatory Affairs. Some good places to start are the EMA and the ICH websites.
• Learn how to use MS Office and Adobe Acrobat proficiently.

Be realistic about your expectations:

Our survey recipients were also keen to highlight the importance of keeping your expectations realistic when you are looking to make that move into Regulatory Affairs. Some specific advice they have provided includes:

• Be prepared to go into Regulatory Affairs at a lower level than you think you should be at.
• Be prepared to work hard and start with the basics – if you can’t get that right, it will be difficult for you to progress your career in Regulatory Affairs.
• Consider Regulatory Administrator positions as a starting point, as well as Quality Control positions if you are looking to get into the Chemical industry.

Choose the right company:

Lastly, one of the commonly overlooked factor many entry level candidates over look when they are looking to get into Regulatory Affairs is the type of company they want to work for. Our survey recipients made some great points here which you should consider:

• Choose a company which is going to be committed to your career development who can provide you with specific Regulatory training and than will set up clear milestones for your progression.
• Don’t just focus on companies within the pharmaceutical industry
• Keep an open mind when it comes to the type of company, whether it be large or small, each will have their benefits.