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 range of companies, meet the required legislation.
They advise on and coordinate the approval and registration of:
- pharmaceuticals;
- veterinary medicines;
- complementary medicines;
- agrochemicals;
- pesticides;
- therapeutic devices;
- cosmetics;
- other products.
Responsibilities
It can take up to 15 years to develop and launch a new pharmaceutical product and a regulatory affairs officer will be involved throughout the process, right from the start. Typical activities include:
- ensuring that a company's products comply with the regulations of the MHRA;
- keeping up to date with 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.
Working hours
Working hours can include regular extra hours to meet tight deadlines, but not weekends or shifts. There are also some opportunities for part-time work.
What to expect
- This is a desk-based role, involving the close study of scientific and legal documents. It also requires close working with scientific and medical personnel, often on a project-team basis.
- Regulatory affairs roles have considerably broadened in scope within the last few years and usually entail involvement throughout the lifecycle of a product.
- Work in larger companies is often in their regulatory affairs departments, while smaller companies may employ only one or two specialist staff.
- Self-employment is usually possible. Freelance work through agencies is possible with experience. There is a growing trend for companies to contract out regulatory and related specialist services, giving increasing opportunities for progression into consultancy for experienced professionals.
- Although there is a concentration of healthcare companies in London and the South East, the M4 corridor and Cambridge areas, small start-up and device companies are more evenly spread throughout the UK.
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