Regulatory affairs officer : Job description

Regulatory affairs officers ensure the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of products.

They combine their knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by a wide range of companies, meet the required legislation.

They advise on and coordinate the approval and registration of pharmaceuticals, veterinary medicines, complementary medicines, chemicals, pesticides, therapeutic devices and other products.

Regulatory affairs officers are the crucial link between their company, its products and regulatory authorities, including the Medicines and Healthcare products Regulatory Agency (MHRA) , the US Food and Drug Administration (FDA)  and the European Medicines Agency .

Typical work activities

Typical work activities include:

• ensuring that a company's products comply with the regulations of the Medicines and Healthcare products Regulatory Agency (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 licences and licence renewals;
• preparing submissions of licence variations and renewals to strict deadlines;
• monitoring and setting timelines for licence variations and renewal approvals;
• working with specialist computer software and resources;
• writing clear, accessible product labels and patient information leaflets;
• planning and developing product trials and interpreting trial data;
• advising scientists and manufacturers on regulatory requirements;
• project managing teams of colleagues involved with the development of new products;
• undertaking and managing regulatory inspections;
• reviewing company practices and providing advice on changes to systems;
• liaising with, and making presentations to, regulatory authorities;
• negotiating with regulatory authorities for marketing authorisation;
• specifying storage, labelling and packaging requirements.