Senior Regulatory Affairs Officer

Job Description:

Job Description:

          To assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials. 

• ensure that a company's products comply with the regulations of the regions where they want to distribute them
• keep up to date with national and international legislation, guidelines and customer practices
• collect, collate and evaluate scientific data from a range of sources
• develop and write clear arguments and explanations for new product licences and licence renewals
• prepare submissions of licence variations and renewals to strict deadlines
• monitor and set timelines for licence variations and renewal approvals
• work with specialist computer software and resources
• write clear, accessible product labels and patient information leaflets
• plan and develop product trials and interpret trial data
• advise scientists and manufacturers on regulatory requirements
• provide strategic advice to senior management throughout the development of a new product
• project manage teams of colleagues involved with the development of new products
• undertake and manage regulatory inspections
• review company practices and provide advice on changes to systems
• liaise with, and make presentations to, regulatory authorities
• negotiate with regulatory authorities for marketing authorisation
• take part in the development of marketing concepts and approve packaging and advertising before a product's release.