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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.

Requirements:

BACKGROUND

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

Global HQ / Office Based

 

PRIMARY DUTIES

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

 

QUALIFICATIONS / EXPERIENCE REQUIRED:

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.

 

TO APPLY:

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

 

Keyword:

EU Regulatory Labelling Manager / Global Regulatory Labelling Manager / EU Reg Manager / Global Regulatory  Manager / Reg Labelling Manager / Regulatory Affairs Labelling Manager / Careers / regulatory submissions jobs / reg labelling roles / regulatory labelling vacancies / opportunities / London / Berkshire / Maidenhead / Reading / Bracknell / Marlow / Henley / High Wycombe / Uxbridge / Labelling & Artwork Team Manager / Labelling & Artwork Manager

 

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market

Visit us at www.axess.co.uk

 

Apply for this job:  PW-6975 Global Regulatory Affairs Labelling Manager

Contact Information:

Address:  Head Office
Isabella House,
12 Union Court,
Richmond upon Thames,
Surrey
TW9 1AA
England
Tel:  +44 (0)20 8560 2300
Fax:  +44 (0)20 8560 2033
Website:  Visit Our Web Site

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