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Job Details

Senior Regulatory Officer, Regional Labeling

Company: Key People Limited
Location: Hertfordshire
Reference: BBBH22457
Closing Date: 24 Aug 17
Type: Permanent
Salary (£): 30,000 - 40,000
Benefits:

Job Summary:

An excellent opportunity has arisen for an experienced and driven candidate to join the labelling team within a global healthcare company based in Hertfordshire. You will be responsible for authoring and maintaining SmPCs and PILs, as well as responding to questions from authorities and supporting central regulatory teams.

Requirements:

An excellent opportunity has arisen for an experienced and driven candidate to join the labelling team within a global healthcare company based in Hertfordshire. You will be responsible for authoring and maintaining SmPCs and PILs, as well as responding to questions from authorities and supporting central regulatory teams.

Responsibilities:
• Connect, collaborate and communicate with internal and external customers to achieve business goals
• Member of a dedicated Regulatory team managing safety updates to product information for the European generic portfolio
• Authoring and maintenance of the SmPC, Package Leaflet (PL) and Labelling in compliance with the reference product, other safety information, CMC and relevant Labelling legislation and guidelines
• Responding to questions and requests from European health authorities and the EMA
• Supporting the Central Regulatory team with submission-ready documents and strategy

Experience Required:
• Experience in Regulatory affairs, preferably including management of Labelling documents
• Knowledge of the lifecycle and maintenance of product information
• Understanding of key legislation, templates and guidelines governing Labelling within Europe
• Proficiency in speaking, comprehending, reading and writing English

For further details, please contact Tim Barratt on (0)1727 817 626 or email your CV to tbarratt@keypeople.co.uk

Apply for this job: Senior Regulatory Officer, Regional Labeling

Contact Information:

Address:  Head Office
Catherine House
Adelaide Street
St Albans
Hertfordshire
AL3 5BA
England
Tel:  Tel: 44 (0) 1727 811634
Fax:  Fax: 44 (0) 1727 844838
Website:  Visit Our Web Site

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