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Regulatory Affairs Manager - LondonRef: 24506

Salary:£40000 - £60000 per annum + benefits

Added:22 Nov 2019

Region: South East

Sector: Pharmaceutical

Sub Sector: Regulatory Affairs

I am currently recruiting for a Regulatory Specialist / Manager to join an exciting company based in London. Within this role you will work with the Head of R&D, to organise and manage the Regulatory Affairs function. This will include responsibility for performing, reviewing and approving regulatory affairs activities, including the application for New Product Registrations (MAAs), maintenance of existing Product Registrations (Variations and Renewals). General Responsibilities: *Management of Regulatory project work/project lead. *Preparation and coordination or review of documentation or dossiers. *Regulatory strategy (pre-submission or post-approval stages) *Maintaining an awareness of the EU Regulatory landscape (Pharmaceutical & Device) and changing regulatory requirements Key Responsibilities: *Preparation and project management of Pharmaceutical Marketing Authorisation Applications (MAA) & Medical devices (STED) *Artwork management on medical devices and pharmaceutical products. *Preparation and review of responses to questions *Preparation and review of post-approval/Variation and Maintenance submissions *Dossier reviews and gap analyses *Interact and negotiate directly with regulatory authorities and notified bodies. Assisting with Scientific Advice procedures Knowledge and Experience: *Proven experience in a similar Regulatory Affairs role working with pharmaceuticals/medical devices with knowledge of the Medical Device Directive (MDD), Medical Devices Regulation (MDR), *Ideal candidate would have around 5 years' experience in Full lifecycle regulatory affairs within Pharmaceutical and or medical devices. *Experience in developing regulatory affairs strategy, and interpreting, implementing and communicating regulatory changes, and developing team members. *Knowledge of US and international medical device regulatory requirements, procedures, regulations For further information, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk

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