The work of a Regulatory Affairs Officer is to ensure the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of products.
The role involves combining their knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by a wide range of companies, meet required legislation.
They advise on and coordinate the approval and registration of pharmaceuticals, veterinary medicines, complementary medicines, agrochemicals, pesticides, therapeutic devices, cosmetics and other products.
Regulatory affairs officers are the crucial link between their company, its products and regulatory authorities such as the Health Products Regulatory Authority (formerly the Irish Medicines Board) and the European Medicines Agency (EMA).
It takes up to 15 years to develop and launch a new pharmaceutical product. The Regulatory Affairs Officer will be involved from the beginning and throughout the process.
This is a desk-based role, involving the close study of scientific and legal documents. It typically requires working closely with scientific and medical personnel on a project or team basis.
Typical work activities include:
- Ensuring the company's products comply with the regulations
- Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to
- Collecting, collating and evaluating scientific data that has been researched by colleagues;
- 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
- Providing strategic advice to senior management throughout the development of a new product
- 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