Pharmacistweb has been exploring different roles within the Pharmaceutical industry, and one such role we wish to discuss today is regulatory affairs. Often a role of which many pharmacist move into within the pharmaceutical industry.
What happens in regulatory affairs?
Pharmacistweb has spoken to those working in regulatory affairs, and we are pleased to inform you that the role is broad but generally revolves around the products license. Regulatory affairs are involved through the product life-cycle from its conception2. Regulatory affairs are consulted frequently by various departments such as marketing, medical information, pharmacovigilance and much more. There are various reasons why these departments contact regulatory affairs, but below are a few examples to help you understand.
- Marketing: they often liaise with regulatory regarding the product license, marketing would like to know how long it will take for a product to gain approval by the regulatory authority. This is crucial to allowing marketing to plan their strategy and forecast the cost of marketing the product.
- Medical information: often contact regulatory, to identify key details regarding the drugs dossier. Such details may include how was the product made, or what are the specific details of the product. Medical information may request such information to assist a Pharmacist or a patient who is allergic to certain excipients
“you may be involved from the birth of a product to the end of the product”
Regulatory affairs, often requires an ‘eye’ for detail and a good understanding of regulations (i.e. MHRA, EMA). It is crucial, as you will be submitting applications for a product license to the appropriate regulatory body. And, these licenses are not cheap! Furthermore, you will be responsible for updating and maintaining the license.
What skills are important for regulatory affairs1?
- Relevant aspects of law: it is important that you are conscience of how you store documents.
- Toxicology, Clinical and scientific skills: although regulatory affairs may seem like a role which involves a lot of paper work, there are loads of opportunities to utilise your clinical and scientific skills. In fact these complement the role.
- Pharmaceuticals and Toxicology: Yes, we said it ‘pharmaceuticals’, hope you still have a copy of your ‘Altons pharmaceutics’
What is the salary like?
Well it depends, as a pharmacist moving into regulatory affairs you are likely to take a pay cut. There may be a pay rise if you move straight from pre-registration to regulatory affairs, also it depends on the role you ascertain. Most pharmacist moving into the pharmaceutical industry will begin at a junior level. This is usually as a regulatory affairs officer, they then grow into associates, and can then move into managerial roles.
The salary for an officer, typical starts at £18-23k, but with increase experience salary rises to £30-55k1. if you make It to a director level, then you could earn in the region of 100k. The salary will vary according to prospects.ac.uk depending on the location, region, and company.
How can I get into regulatory affairs?
If we haven’t lost you by now you are clearly still interested. You will be pleased to know that pharmacy falls within the relevant degrees for regulatory affairs. However, you can also make yourself more appealing to the industry by attaining a qualification (MSc regulatory affairs) from The Organisation for professionals in Regulatory Affairs (TOPRA)1.
If you are interested in learning about an MSc in regulatory affairs please click the link below
Also, apply for entry roles, these are rare but they do come around.
Pharmacistweb.com believes that pharmacist are more than capable of working in the industry. All the skills listed are all transferable skills of which majority of pharmacists possess.
We hope this has been useful.