Global Regulatory Affairs Labelling Manager

Recruiter
Axess Ltd
Location
London (Greater)
Posted
13 Nov 2017
Closes
15 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Global Labelling Manager opportunity within a Biopharma. Permanent position, office based to the West of London.

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.

Benefits:

Competitive including Bonus, Pension, Life Assurance, Private Medical and Parking

TO APPLY:

For a confidential discussion please telephone Christian Simon at AXESS Limited on ************** To apply, please send your CV to **************** quoting reference EM-6975

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