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, agrochemicals, pesticides, therapeutic devices, cosmetics and other products.
Regulatory affairs officers are the crucial link between their company, its products and regulatory authorities, including the:
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 beginning. Typical activities include:
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