You’ve heard of companies having research and development departments, you know all medicines start off as molecules in a lab but do you know what it takes to get the product on the shelves? Everyone knows medicines must go through vigorous testing and pass regulations before they are deemed safe for patients, but did you know there is an internal team who ensures the product is developed and manufactured in accordance with regulations and directives, the product is safe and effective? A somewhat unknown department to the public, Regulatory Affairs. Regulatory Affairs professionals help write and compile the dossier/documentation and submit initial marketing authorisations to obtain marketing authorisatons in the desired Health Authorities.

How does the department fit into a Pharmaceutical Company?

In order to gain a marketing authorisation, companies need to work collaboratively. There are so many different departments within Regulatory Affairs however the goal is common, compile an outstanding dossier to the Health Authorities to gain approval, as quick as possible. Regulatory Affairs professionals work alongside key departments such as R&D, portfolio, supply chain, artwork, medical, clinical and the list goes on, to compile said dossier. As experts in guidelines, regulations, legislations and directives, we provide advice in accordance with the requirements of the region the product is intended to be marked in.

Why Regulatory Affairs?

Every colleague in a Pharmaceutical Industry plays a huge role in delivering safe and effective medicines to patients. It is a sense of pride when a family member tells you they are taking medication manufactured by your company, and you have played a key part in obtaining the marketing authorisation for the product in that market. You are the one who submits the information to the Health Authorities, you are the one in direct contact with the Authority, you are the one who receives the approval. Without the authorisation you helped obtain, the family member would not have received the product.

What do you do once you receive the initial authorisation?

Of course the core part of the Regulatory role is obtaining the initial marketing authorisation however the story does not stop there. Post-approval activities take place the entirety of the products life, and it is Regulatory professionals responsibility to maintain the product by submitting variations when there is a manufacturing change, change of product name, change in product information, update in safety information and the list goes on.

Only medicines?

No! Regulatory Affairs exists for many different types of products! Food supplements, cosmetics, medical devices, biocides.. 

Routes you can take

There are many degrees that can land you a role as a Regulatory Affairs professional – biology, chemistry, pharmacy, pharmacology, pharmaceutical science….

Some professionals decide from graduating they would like to step into the world of Regulatory, and some pursue other career opportunities before landing into Regulatory. This includes working in the labs, pharmacies and even in Health Authorities!

What can we do for you?

Whether you are starting out in the industry or already work within the industry and want to make the move across to Regulatory Affairs, we are here to help! We want to help prepare you for the job you aspire to do by reviewing your CV, helping with job searches and explaining job descriptions in detail, and also providing mentoring sessions to help with any topic you may wish to know more about. If there is anything you cannot find on our website, please do not hesitate to reach out to us!