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Regulatory Officer, Central LondonRef: 1602-2

Salary:£35000 - £40000 per annum + bonus and benefits

Added:10 Jan 2018

Region: London

Sector: Pharmaceutical

Sub Sector: Regulatory Affairs

An excellent opportunity has arisen for a Regulatory Officer to join a Pharmaceutical company based in central London. Within this role you will be responsible for registering an exciting range of new products and maintaining a European Portfolio. This role has become available due to an ongoing period of growth within the company and your responsibilities will be split across Regulatory, PV and Quality. Responsibilities include: *Ensure regulatory submission (DCP's, MRP's and National applications) are completed in a timely manner using eCTD *Perform routine regulatory activities (i.e. maintenance/renewals, variations, 61(3) notifications) *Aid in technical input where required *Ensure artworks are created and approved in time for product launches *Maintain current knowledge of regulatory affairs legislation *Ensure all regulatory databases are kept up to date *Provide support for marketing material 2. Pharmacovigilance *Ensure pharmacovigilance activities performed are completed in a timely manner, and in accordance with pharmacovigilance legislation *Ensure PSUR's are submitted in accordance with agreed schedules *Maintain effective dialogue with pharmacovigilance contract providers *Ensure regulatory changes to product information are provided in a timely manner to the pharmacovigilance contract provider and all relevant departments 3. Quality Assurance *Prepare and maintain Product Compliance Files *Review of validation documents *Ensure Quality systems are maintained *Ensure retained samples are stored in accordance with SOP *Prepare/review SOP's where required For further details about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy of your CV to Key People is a recruitment consultancy with a reputation for providing good value that's been built up over 20 years. Clients come to us for three main reasons: > We achieve results faster > Our candidates really are a cut above > We add greater value We think it's because we're a private company driven by clients, not by shareholders. For our candidates, we have developed relationships with thousands of clients nationwide, throughout Europe and also many around the globe, who choose to recruit through Key People, so you'll have a wide choice of opportunities to further your career. And, as we work for 75% of FTSE 100 companies, you'll get the chance to work for some prestigious, blue-chip organisations.

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