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Job Details

Regulatory Affairs Labelling Manager

Company: Regulatory Professionals
Location: Uxbridge
Reference: J31388
Closing Date: 14 Dec 17
Type: Contract
Salary (£): Negotiable
Benefits: Competitive + Benefits

Job Summary:

Regulatory Affairs Labelling Manager Regulatory Professionals are working with a European pharmaceutical company based in Middlesex who are seeking an experienced Labelling Manager work on a variety of products, including gastroenterology and oncology.

Requirements:

Regulatory Affairs Labelling Manager
Uxbridge, UK
6- 12 month contract
Job Ref: J31388

Regulatory Professionals are working with a European pharmaceutical company based in Middlesex who are seeking an experienced Labelling Manager work on a variety of products, including gastroenterology and oncology. As a member labelling and artwork team to you will manage all regulatory activity related to the maintenance of Company Core Datasheets (CCDS).

Responsibilities include:
* Managing the maintenance of Company Core Datasheets (CCDS) and any changes and safety related variations associated with CCDS.
* Coordinate submission of safety documentation and liaising with relevant departments to ensure submission requirements are met.
* Represent Regulatory Affairs on the Labelling Committee and provide advice on safety related matters.
* Coordinate all activities associated with the Labelling Committee.
* Act as the Regulatory point of contact for all Labelling queries and provide guidance on labelling requirements.
* Track local SmPCs and collate regulatory input into PSURs and ensure all PSUR Regulatory Data documents are completed on schedule.

Candidate requiements include:
* Bachelor's degree or equivalent in a life science subject
* Broad regulatory experience of working at a senior level
* Full strategic understanding of drug development and life-cycle management processes
* Subject matter expertise in Regulatory Labelling and experience working with CCDS and SmPCs
* Line Management experience
* Experience working with commercial needs

Alternatively, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if they are successfully place then you'll receive £250 worth of vouchers of your choice.

Labelling, Line Management, Regulatory, Company Core Datasheets, Uxbridge, Middlesex, London, drug development, LCM

Apply for this job: Regulatory Affairs Labelling Manager

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
RG1 1LG
England
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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