Principal regulatory affairs officer

Key People Limited
St Albans
£40k - £50k pa + bonus
07 Nov 2017
15 Nov 2017
Contract Type
Full Time
each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will help: -Ensuring that a company's products comply with the regulations of the MHRA/HPRA -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 *Advising scientists and manufacturers on regulatory requirements *Project managing teams of colleagues involved with the development of new products *Undertaking and preparing for 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
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