The Role:The Hub Labeling project manager is primarily responsible for preparation of local product documents and their associated Local Language documents for their assigned...
The Hub Labeling project manager is primarily responsible for preparation of local product documents and their associated Local Language documents for their assigned markets, updating the labelling documents on a timely basis according to internal SOPs and external regulatory requirements.
- 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
- Effective liaison across key stakeholder and customer groups
- Communication, planning and prioritization to deliver labelling 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 labelling expertise
- Utilisation of analytical skills to review and develop appropriate content for local labelling documents, based on core content, also recording the decisions made
- Working within a framework of internal SOPs and working practices, and external regulatory requirements
- 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 can be triggered in a timely fashion.
- Bachelor's degree in any life sciences
- 1 year of pharmaceutical experience desired
- Language abilities in French (Arabic too would be advantage but not essential).
- The role is to support the impact of Brexit in AfME.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.