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regulatory labelling manager

  • Scientific
  • Walton on Thames
  • £23.00 - £40.00 per hour
  • Temporary
  • Full Time
  • 240AB1
  • 07 Jun 2018
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Our global leader in pharmaceuticals is currently seeking a Regulatory Labelling Manager to support the impact of Brexit in AfME.

This position reports to the locally based Regional Labeling Head, International Labeling Team Lead, or to a Senior Manager in International Labeling Group.
This position will engage with project managers supporting global initiatives and may support other Hub Labeling Managers in terms of ongoing activities.

Position Purpose
The Hub Labeling project manager (HLM) is primarily responsible for preparation of local product documents (LPDs) and their associated Local Language documents (LLDs) for their assigned markets, updating the labeling documents on a timely basis according to internal SOPs and external regulatory requirements. The HLM may also be asked to provide support to the downstream markets impacted by updates to labels in their primary assigned markets.
The HLM in this is role will additionally provide project management support for global initiatives in line with assigned responsibilities, working in close collaboration with the project management team and liaising across regional hub teams as required.
The HLM is a Subject Matter Expert (SME) on local, regional and multi-country regulatory labelling requirements and participates in the sharing of intelligence. The role requires the use and development of current and new tools, technologies and processes to support global label development, submission and approval in respective countries.

Primary Responsibilities
Key activities include:
Project management support for global initiatives in line with assigned responsibilities and working to timeframes defined by the project team
Identification, escalation and tracking of issues, gaps, challenges, risks and actions identified

Interaction with other cross functional roles in the delivery and management of labeling text through the appropriate processes and systems
Communication, planning and prioritization to deliver labeling documents according to company targets and submission requirements ; liaison with stakeholders using the most effective means of communication; presenting information in an optimal format and level of information for that audience.
Development of subject matter expertise for assigned markets or products, and ongoing development of labeling expertise
Utilisation of analytical skills to review and develop appropriate content for local labeling documents, based on core content, also recording the decisions made
Supporting the use of relevant tools and technologies within the course of the label development and translation process
Utilisation of regulatory expertise to review, develop and deliver core/local labelling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting medical advice from others when appropriate.
Engagement in necessary labelling team meetings to discuss any decisions for not making any label updates or discuss any findings of meaningful differences for registration types specific to USPIs, CRP-SmPCs and MRP/DCP-SmPCs as necessary.
Ensuring that decisions taken for labelling are accurately captured and communicated to appropriate stakeholders so that local and regional submission activities.

Technical Skill Requirements
* Knowledge of global/regional regulations and guidelines pertaining to labeling, and/or general regulatory background/experience, potentially gained in a country office environment, is preferred.
* Ability to understand, analyze and propose information into local labeling such as the LPD and Patient information and ability to logically review any impact on other sections of the same documentation

Qualifications
* 1 year of pharmaceutical experience desired
* We would like to look for language abilities in French (Arabic too would be advantage but not essential).

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