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Job Details

Labelling Manager

Company: Regulatory Professionals
Location: London
Reference: J31124
Closing Date: 20 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits: Circa £50,000 per annum plus benefits

Job Summary:

Labelling Manager Regulatory Professionals are working with a European pharmaceutical company based near Uxbridge that work on a variety of products, including gastroenterology and oncology.

Requirements:

Labelling Manager
Uxbridge, UK
Salary: Circa £50,000 per annum plus bonus, pension, healthcare, & 25 days holiday
Permanent Position
Job Ref: J31124

Regulatory Professionals are working with a European pharmaceutical company based near Uxbridge that work on a variety of products, including gastroenterology and oncology. This company are looking for an experienced Labelling Manager to join their labelling and artwork team to manage all regulatory activity related to the maintenance of Company Core Datasheets (CCDS).

Job responsibilities include, but are not limited to:
* 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.

The ideal candidate will possess the following skill set:
* 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: 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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