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Role Filled
Senior Regulatory Affairs Officer
Pharmaceutial & Biotechnolgy
Technical Specialist
Regulatory Affairs
Kent or Cheshire
£Speak with Marcus
Role Overview
Regulatory Submission’s / reporting to regulatory authorities
Escalating things to senior management
Complete project plans / variations in line with timescales
Company Information
My client is a privately owned British company offering a range of medicines, medical devices, unlicensed medicines, and OTC products.
Since it was established, my client has developed a differentiated portfolio of over 150 Market Authorisations, holds the ISO13485 accreditation and is the legal manufacturer and distributor of a range of medical devices.
Our commercial coverage extends across the entire UK mainline and shortline wholesale channels, private and NHS hospitals, community and retail pharmacies and Clinical Commissioning Groups.
Role Requirements
Manage life cycle/ post-authorisation changes for UK relating to CMC, clinical, safety and product Information changes.
Writing, Compiling and Publishing Dossiers for UK National & EU Submissions.
Compiling information and data for amendments to marketing authorisations. Submitting the variations to marketing authorisations and working with the MHRA and other regulatory bodies to resolve any RFI’s arising during review of these variations.
Develop and approve artwork components and patient information (SPC, PIL, cartons and labelling) and associated mock-ups.
Prepare Artwork Submissions that include P1 Applications, Article 61 (3) Notifications
Liaise with the External Pharmacovigilance consultants for submission of Safety variations and PSUSA Variations.
Person Specifications
Regulatory / PV experience within Pharmaceuticals
UK / EU experience
Commutable to East London or Chester
Package
Competitive basic salary
Bonus
Wider benefits package
Locations
Accrington
Altrincham
Ashford
Ashton-under-Lyme
Bangor
Banstead
Basildon
Beckenham
Benfleet
Bexley
Birkby
Blackburn
Blackpool
Bolton
Bootle
Bradley
Bromley
Burnley
Bury
Buxton
Camberwell
Carshalton
Caterham
Cheadle
Chertsey
Chessington
Chester
Chigwell
Chorley
Clapham
Conwy
Crawley
Crewe
Croydon
Dagenham
Dartford
Darwen
Deeside
Deighton
Denbigh
Deptford
East London
Elland
Ellesmere Port
Epsom
Fleetwood
Gatwick
Gravesend
Grays
Greenwich
Halifax
Haywards Heath
Hebden Bridge
Hornchurch
Horsham
Huddersfield
Hyde
Ilford
Kingston-upon-Thames
Leatherhead
Leek
Leigh
Lewisham
Leyland
Leyton
Liverpool
Llandudno
Loughton
Ludlow
Macclesfield
Maidstone
Manchester
Market Drayton
Medway
Mitcham
Morden
Nantwich
Northwich
Oldham
Ormskirk
Orpington
Oswestry
Poulton-Le-Fylde
Prescot
Preston
Purley
Putney
Rayleigh
Redhill
Rochdale
Romford
Runcorn
Sale
Salford
Sandbach
Sevenoaks
Shifnal
Shrewsbury
Sidcup
Skelmersdale
South East London
South West London
Southend-on-sea
Southport
Sowerby Bridge
St Helens
Stockport
Stoke-on-Trent
Stone
Stratford
Sutton
Telford
Thornton-Cleveleys
Tonbridge
Tunbridge Wells
Upminster
Uttoxeter
Walthamstow
Wandsworth
Warrington
Wickford
Widnes
Wigan
Wimbledon
Wirral
Wrexham
Previous Listing
Date Updated
27 Aug 2024
Job reference
73048
Categories
Full Time
Permanent
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