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Labelling Manager

Job Field:
Regulatory and Drug Safety Jobs
Discipline:
Regulatory Affairs Jobs
Country:
United Kingdom
Region:
Hertfordshire
Contract Type:
Temp / Locum / Contract
Currency:
£
Salary:
45 to 58 per hour
Posted:
29-Jan-20
Recruiter:
Key People
Job Ref:
BBBH24752

An excellent opportunity has arisen for a Regulatory Labelling Manager to join a global pharmaceutical company based in Hertfordshire. Within this role you will lead and support the product teams on the overall development, optimization and implementation of regulatory labelling strategy.

Responsibilities:
Drives and optimizes the strategy for the creation and maintenance of Core Data Sheet (CDS). Provide guidance and expertise to product teams on CDS supporting documents
Authors and maintains CDS, as well as manages the CDS processes in collaboration with regulatory product responsible and product team.
Drives and optimizes the strategy for the creation and maintenance of EU and US product information package. Authors and maintains these product information documents. Leads/contributes company responses to HA questions pertaining to EU and US labelling.
Provides regulatory strategic recommendations concerning acceptable labelling in regional markets, in collaboration with the relevant functions.
Guides and supports the implementation of CDS into the Local Product Labels and manages local label deviations.
Gives specific guidance on labelling regulatory issues such as legislation, guidelines, procedures to the Project teams.
Leads or contributes to establishment or improvement of working processes and standards

Education:
* Bachelor's degree or equivalent in life sciences or other relevant fields

Experience, Knowledge and Skills:
In-depth insight in regulatory affairs (preferably strategic labeling). Knowledge in market access is a plus.
Proven ability to lead cross-functional matrix teams with strong influencing skills.
Good interpersonal and verbal communication skills
3-5 years' experience
Experience in Pharma - labelling and regulatory
Managing the group - data sheets, looking after EU and US labels.
Cross-functional experience required.

Home working, will be assessed after 3 months of office working

For further details, please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk

Closing Date:
26/02/2020

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