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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

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    First Name*

    Last Name*

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    Further Details/Cover Note

    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
    Date Updated
    30 Apr 2024
    Job reference
    73048
    Categories
    Full Time
    Permanent
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    Hiring contacts
    Marcus
    Marcus Chalk
    01494 818 003
    Tom B 3x4 2024
    Tom Bruton
    01494 818 015
    Apply for this role

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    In house, contracting department.

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    03
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