Key Responsibilities:To have an in-depth scientific and regulatory knowledge of the therapeutic area and regulatory landscape in Europe, Turkey, Israel and Switzerland providing comprehensive regulatory...
The Hub Labeling 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.
- Interaction with other cross functional roles in the delivery and management of labelling text through the appropriate processes and systems
- Communicate, plan, prioritize and deliver labelling documents according to company targets and submission requirements ; liaise 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.
- Ensure 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.
- Knowledge of global/regional regulatory regulations and guidelines pertaining to labeling, and/or general regulatory background/experience, potentially gained in a country office environment, is preferred.
- Ability to understand, analyse and propose information into local labelling such as the LPD and Patient information and ability to logically review any impact on other sections of the same documentation
- Degree in any life sciences
- Working experience within a Regulatory Affairs environment
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.