Regulatory Affairs Officer Jobs

Regulatory affairs officer jobs 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.

Regulatory affairs officer jobs advise on and co-ordinate the approval and registration of pharmaceuticals, veterinary medicines, complementary medicines, chemicals, pesticides, therapeutic devices and other products.

Regulatory affairs officer jobs 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).

Regulatory affairs officer jobs duties include:

• 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