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Regulatory Labelling Lead - homebased

Regulatory Labelling Lead, permanent, homebased

Your new company
This growing Regulatory Affairs consultancy is looking for a Regulatory Labelling Lead on a permanent basis, this job will be working solely on one of their key clients’ portfolios, this client is a global, top 5 pharma.

Your new role
As Regulatory Labelling Lead you will have overall accountability for the initial creation and relevant updates to labelling documents for their assigned products. This includes guiding the Labelling Team to develop and maintain Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labelling Documents.
This may also include Regulatory Authority driven documents such as the Core Safety Profile As Labelling Lead you will provide project management to the Labelling Team throughout the entire process, from the decision to update a CDS/USPI/SPC through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements.

What you'll need to succeed
In order to be considered for this permanent, home based Labelling Lead you must have knowledge of global/regional regulations and guidelines pertaining to labelling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels across the regions.
You must demonstrate knowledge and understanding of company Core Data Sheets and the dynamics of Labelling Team purpose and objectives and demonstrate ability to understand how updating one section of a label may impact another and to propose recommendations to the Labelling Team

What you need to do now
For more information on this, or any other Regulatory Affairs Labelling jobs please apply to this advert and ask for Victoria Dunlop


Job Type:
United Kingdom
Life Sciences
£50000 - 75000 + bonus
Apply Now

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