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Job Details

Regulatory Affairs Labelling Coordinator

Company: Regulatory Professionals
Location:
Reference: J23881
Closing Date: 05 Jan 17
Type: Contract
Salary (£): On Application
Benefits: up to £42 per hour

Job Summary:

Regulatory professionals are seeking to hire an adept regulatory affairs labelling coordinator to operate on a 6 month contract for a renowned pharmaceutical global innovator.

Requirements:

Regulatory Affairs Labelling Coordinator
Location: Buckinghamshire
Rate: up to £42 per hour
Duration: 6 months
Reference: J23881

Regulatory professionals are seeking to hire an adept regulatory affairs labelling coordinator to operate on a 6 month contract for a renowned pharmaceutical global innovator.

The successful Labelling coordinator will support the submissions of compliant local labels on time through quality checking of all labelling documents in EMEA, Latin America and Asia Pacific.

Main duties and responsibilities:
* Maintain oversight of compliant labels for EMEA, Latin America and Asia Pacific.
* Ensure updates are integrated into the latest available local label in a compliant manner.
* Archive/ Store the local label in English and local language in a central repository.
* Initiate content deviation process, if required ensure updates are integrated into artwork in a compliant manner.

The optimal candidate for this role will have:

* A minimum of 3+ years' regulatory labelling experience.
* Analytical skills and technical RA knowledge, alongside the ability to assess impact of Label change on current situation.
* Detail-orientation combined with being able to take a step back (helicopter view)
* Concern for Quality and Order.
* Proficient in English (incl technical RA English)
* Team player able to effectively collaborate with colleagues in virtual environment and able to do efficient handovers.
* Able to influence without authority - experience in a matrix structure.
* Able to make independent decisions.
* Knowledge of regulatory IT systems (especially document management and planning)
* Language capabilities: fluent in English, generic feel for languages.

Opportunities to work for this business on a contract basis do not come about very often and therefore if you are interested please call 0118 952 2797 to have a confidential chat about your search.

Keywords: Regulatory Affairs, Regulatory Affairs Project Manager, Regulatory Affairs Labelling Coordinator, Reg Affairs Labelling, Label, Artwork, Middlesex, Berkshire, Buckinghamshire, Hertfordshire, SmPC, PILs, CCDS,

Apply for this job: Regulatory Affairs Labelling Coordinator

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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