Regulatory Executive: Labelling, Brexit
In this role the individual is responsible to their line function for the timely provision of support for documentation:
• Independently manage the maintenance of the EU Product Information for Prescribing/Patient/Packaging Information, primarily for products registered via centralised and in relation to Brexit related activities.
• To support regional and country product information (prescriber and patient), APJEM markets.
Responsibilities and Accountabilities
The role is accountable for:
• Updating EU CP documents with Brexit related updates
• Provision of labelling support for products registered via EU centralised procedure in accordance with EMA and GSK guidelines and deadlines.
• Assuring quality and consistency of labelling documentation.
• Supporting GRA-labelling processes and systems in accordance with GSK policies and procedures.
Dependent of the level of experience, this role may require:
• Provision of labelling support for products registered via EU centralised procedure in accordance with EMA and GSK guidelines and deadlines, including support for LOCs and management of product information annexes during the EU linguistic review process.
• Management of GRA Labelling data and documents in regulatory systems such as OPAL and IMMS, Veeva Vault, together with upload onto other GSK systems.
• Provision of support for GRA Labelling staff in their role to develop and maintain Global PI for Prescribing/Patient/Packaging Information, and their support for regional and country product information (prescriber and patient), primarily in the EU and APJEM markets.
• Management of the development and maintenance of EU CP and MR/DCP labelling documents and IPI throughout the product lifecycle.
• Awareness and application of relevant pharmaceutical regulation and new guidelines/policies relevant to product information. Participation in other projects and activities, such as contributing to the implementation of changes to processes within GRA Labelling.
• Participation in mandatory training and completion of the training records.
• Experience of supporting products registered via the European centralised procedure.
• Experience of working with and amending EU Annexes
• Experience and familiarity of working within documentum databases, lotus notes databases, Veeva Vault and team sites.
• Familiarity with entry, tracking and registration data management systems would be beneficial.
• Excellent communication skills – internal and external stakeholders
• Attention to detail
• Excellent prioritisation, organisation skills and time/work load management
• Data entry skills
• Team working skills
• Document management skills
• Ability to understand and utilise different systems and databases.
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