Typical RA work activities

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Typical RA work activities

Postby Sae98 » Wed Mar 28, 2007 7:37 pm

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

Regulatory affairs officers on Regulatory Jobs are the crucial link between their company, its products and regulatory authorities, including the concerned national medicines and healthcare agency, the food and drug administration and other related regulatory agencies.

Typical work activities of a regulatory job include:

• Ensuring that a company's products comply with the regulations of the national medicine and healthcare products regulatory agency.
• 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;
• Writing clear, accessible product labels and patient information leaflets;
• Planning and developing product trials and much more.
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