Global Labelling Manager

Key People

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Job ID :

15078


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Oxfordshire,Oxfordshire,


Key Skills :

Labelling, Artwork, Regulatory Affairs, Pharmaceutical, Oxfordshire


Salary :

£45 - £55 per hour


Date Posted :

02 Jul, 2019



Company Name :

Key People


Location1 :

Oxfordshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

My pharmaceutical client in the Oxfordshire area is looking for a Labelling Manager on a 6 month contract.

The Manager Regulatory Affairs Labeling will be responsible for regulatory support (both technical and operational) in the area of product labelling. This position reports to the Head of EU/RoW Labelling & Ad Promo and will be responsible for key functions including creating, updating and maintaining labelling documents throughout the product lifecycle, with primary focus on Company Core Data Sheets and products marketed in EU/RoW. The candidate will help maintain controlled records for historical labelling changes, and communicate labeling changes to stakeholders at the time of implementation. As needed, the candidate will also help to implement process improvement changes to increase the efficiency and effectiveness of the label review process. This position will interact cross-functionally with members of commercial, legal, safety, medical, and others.

Downstream artwork oversight but also some label / SmPC logistics work too (e.g. administration of Ling Review


Essential Job Functions:

Specific responsibilities will include:

*Maintain expertise regarding key labelling requirements worldwide and stay current with labelling guidelines and regulations as they pertain to the development/maintenance of labelling and advise key stakeholders on the application of these labeling principles
*Support maintenance of controlled records for historical, current, and ending labelling changes, and communicate labelling changes to stakeholders at the time of implementation
*Manage quality control over entire labelling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution
*Under the direction of the Head of EU/RoW Labelling, assist in implementing process improvements to increase the efficiency and effectiveness of the label review process
*Work closely with EU/ROW Regulatory Affairs colleagues, Supply chain colleagues, and colleagues responsible for translation processes
*Support project management of the Labelling Team throughout the entire process, from the decision to update a CCDS/USPI/SmPC through notification to stakeholders, to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements
*Responsible for proofreading and departmental QC work
*Support the development of EU/RoW product labelling, including CCDS development, package inserts and equivalents and their associated Patient Labelling Documents
*When developing new labels, research the content of other labels in the same therapeutic class, including competitor labelling, to help guide the team in developing labelling text, including contingency strategy development for negotiation with regulatory authorities.

Minimum Requirements:
*B.S/B.A. (or equivalent in industry related experience)
*Experience in regulatory affairs with particular focus on labelling
*Experience associated with global product labelling regulations strongly desired
*Good judgment and decision making skills and attention to detail
*Excellent written and verbal communication skills
*Ability to review regulatory labelling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
*Must be able to work successfully within a team/partnership environment and as an individual contributor, with a high level of professionalism and use initiative where appropriate
*Ability to work cross functionally and interact effectively with all levels/roles of project team members

Description of Physical Demands
*Responsibilities may require working outside of "normal" hours, in order to meet business demands
*Ability to travel occasionally


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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