Regulatory Affairs Officer Jobs

Regulatory affairs officers ensure the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products

Combining knowledge of scientific, legal and business issues, they enable products that are developed, manufactured or distributed by a wide range of companies to meet the required legislation

They advise on and co-ordinate the approval and registration of pharmaceuticals, veterinary medicines, complementary medicines, chemicals, pesticides, therapeutic devices and other products

The jobs of the regulatory affairs officers are crucial in the link between their company, its products and regulatory authorities, including the Medicines and Healthcare Products Regulatory Affair (MHRA), the US Food and Drug Administration and the European Medicines Agency (EMEA)

Ensuring that a company's products comply with the regulations of the Medicines and Healthcare Products Regulatory Affair (MHRA)

Keeping abreast of international legislation, guidelines and customer practices

Collecting and collating a wide range of information

Keeping up to date with a company's product range

Developing and writing clear arguments and explanations for new product licenses and license renewals

Understanding and evaluating complex information

Working with specialist computer software and resources

Planning and developing product trials

Interpreting trial data

Advising scientists and manufacturers on regulatory requirements

Preparing and co-ordinating documentation

Undertaking and managing regulatory inspections

Reviewing company practices and providing advice on changes to systems

Liaising with, and making presentations to, regulatory authorities

Submitting license and clinical trials applications to authorities to strict deadlines

Negotiating with regulatory authorities for marketing authorization

Specifying storage, labeling and packaging requirements

Generally a Bachelor of Science degree is required and training in the regulatory field is beneficial