People who work in regulatory affairs roles are in the pharmaceutical industry, ensuring appropriate licensing and legal compliance of medical products, which controls the safety of the products.
The job requires knowledge of scientific, legal, and business issues which is then applied to the products developed by a range of companies. Regulatory affairs jobs cover the registration of products such as pharmaceuticals, veterinary medicines, complementary therapy medicines, agrochemicals, pesticides, cosmetics and more.
The importance of the job itself should not be underestimated; it can take up to 15 years to research, develop and produce a pharmaceutical product, and the involvement of a regulatory affairs officer is vital throughout the whole process. They ensure that regulations are adhered to by keeping up to date with relevant international legislation and practices, as well as collating scientific research and data that may impact upon the licence of a new product. Officers also work on developing product trials and analysing the data to then advise on production. Towards the other end of a product’s development, officers in this role will also work on labelling and packaging of the pharmaceutical item in line with marketing legislation. Marketing compliance is also included in this process.
Regulatory affairs jobs will suit dedicated and driven individuals who may come from a background in a range of areas, though a degree in biochemistry, biology, chemistry, life sciences, medicine, pharmacology, and biotechnology is more likely to be applicable when considering career progression.
The skills required for regulatory affairs jobs vary, making it a rich and interesting choice of career. Most applicants in this area have analytical skills, data interpretation skills, good communication skills, legal knowledge or expertise, IT and software skills and the ability to work under pressure and to strict deadlines. The job also requires integrity and team-work skills, owing to the nature of the work undertaken.
Career progression can lead to more involvement in the development of pharmaceuticals and so a more active role in decision-making. There is also the opportunity to become specialised in a specific area, leading to the option of consultancy work at a higher level. Browse our site to find the best regulatory affairs jobs to suit your drive and ambition.
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