REGULATOR AFFAIRS JOB

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 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 ensuring that a company's products comply with the regulations of the 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.

Preparing submissions of license variations and renewals. Setting timelines for license variations and renewal approvals. Understanding and evaluating complex information. Working with specialist computer software and resources. Writing clear, accessible product labels and patient information leaflets. Planning and developing product trials. Advising scientists and manufacturers on regulatory requirements. Resolving complex issues as they arise. Preparing and coordinating documentation.

Project managing teams of colleagues involved with the development of new products. Maintaining quality systems. Undertaking and managing regulatory inspections. Reviewing company practices and providing advice on changes to systems 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 closely with the regulatory authorities on a regular basis.