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Role Filled

Regulatory Manager

Pharmaceutial & Biotechnolgy
Technical Specialist
Regulatory
Berkshire
£Speak with Alex
Generic product (off patent/off brand)

Role Overview

The role will be responsible for manage all aspects of UK Product Registration and communications with the MHRA. The Regulatory Manager will also be responsible for pharmacovigilance reporting.

Company Information

My client are one of the world’s leading generic phamraceutical companies with a portfolio of prescription, non-prescriptions and animal health products. With a global presence my client offer excellent career progression, an excellent reputation and exciting portfolio.

Role Requirements

Monitoring and interpreting of UK regulatory and pharmacovigilance legislation
Development of registration strategies and the preparation of product registrations/variations
Submitting registration documentation to the MHRA/VMD in order to be granted marketing authorisations (MAs) at the earliest opportunity
Checking packaging materials intended for submission to regulatory authorities and before final print in production
Keeping the data base and documentary records on the registration procedures and distributing relevant MA data
Local Responsible Person for Pharmacovigilance
Participate in regulatory agency inspections and audits

Person Specifications

Experience within a similar position (Regulatory Management within Human Pharma)
Strong contact network with the MHRA
Attention to detail
Ideally experience in handling pharmacovigilance

Package

Competative base salary
Contributory pension
Healthcare
Home working (50%)
Group Income Protection Insurance

Locations

Aldershot
Amersham
Aylesbury
Banbury
Banstead
Barnet
Basingstoke
Bicester
Borehamwood
Bracknell
Brent
Broxbourne
Camberley
Camden
Carshalton
Chertsey
Chessington
City of London
Clapham
Dunstable
Ealing
Egham
Enfield
Epsom
Fulham
Greenford
Guildford
Harpenden
Harrow
Hatfield
Hayes
Hemel Hempstead
High Wycombe
Islington
Kingston-upon-Thames
Leatherhead
Leighton Buzzard
Luton
Maidenhead
Marlow
Morden
Newbury
North West London
Northolt
Oxford
Pinner
Putney
Radlett
Reading
Richmond upon Thames
Rickmansworth
Ruislip
Slough
South West London
Southall
St Albans
Staines
Sutton
Twickenham
Waltham Cross
Wandsworth
Watford
Welwyn
Wembley
West Central London
West London
Westminster
Wimbledon
Windsor
Witney
Woking
Wokingham
Previous Listing
Date Updated
16 Jan 2024
Job reference
71250
Categories
Full Time
Permanent
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