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Job Details

PW-6975 Global Regulatory Affairs Labelling Manager

Company: AXESS
Location: London
Reference: PW-6975
Closing Date: 09 Dec 17
Type: Permanent
Salary (£): Competitive
Benefits: Competitive including Bonus, Pension, Life Assurance, Private Medical and Parking

Job Summary:

Global Labelling Manager opportunity within a Biopharma. Permanent position, office based to the West of London.



Exciting Global Pharmaceutical Company – specialist therapy area, proactive acquisition model and strong development opportunities.

Global HQ / Office Based



The Labelling Manager is responsible for planning and managing all regulatory activity associated with maintenance of Company Core Datasheets (CCDS). 

To coordinate the preparation of high quality documentation for safety submissions (variation, PSURs) and liaising with relevant departments to ensure that regulatory requirements for these submission are met.

To manage the processes through which safety related regulatory activities are planned agreed and progressed. 

To co-ordinate all QMS related regulatory activities to ensure compliance with actions.

Manage the preparation of regulatory submissions for those all products in relation to the maintenance of CCDS

To liaise with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met both independently and as directed by line manager

To manage the process through which safety-related regulatory activities are planned, agreed and progressed

To manage submission strategies and plans for Labelling Changes

To represent Regulatory Affairs on the Labelling Committee and provide regulatory advice on safety-related matters



Good degree in a relevant life science subject or equivalent,

Broad regulatory experience, part of which should have been gained operating at a senior level, and good knowledge of worldwide regulatory requirements (including GMP, GLP and GCP)

A full strategic understanding of the drug development and life-cycle management principles and processes

Demonstrates subject matter expertise, e.g., labelling

Demonstrates an ability to analyse and summarise data to a high level


Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.



For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300. To apply, please send your CV to quoting reference PW-6975.



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Contact Information:

Address:  Head Office
Isabella House,
12 Union Court,
Richmond upon Thames,
Tel:  +44 (0)20 8560 2300
Fax:  +44 (0)20 8560 2033
Website:  Visit Our Web Site

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