Regulatory Hub Labeling Manager

Job Ref: J25182
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 26 January 2018
  • Surrey, England, UK
  • Competitive
  • Natasha Rollason

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The Role:

To be responsible for preparation of local product documents and their associated Local Language documents for their assigned markets, updating the labeling documents on a timely basis according to internal SOPs and external regulatory requirements. This role will act as a Subject Matter Expert on local, regional and multi-country regulatory labelling requirements and participate in the sharing of intelligence.

Responsibilities:

  • Engage 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.
  • Interact with other cross functional roles in the delivery and management of labeling text through the appropriate processes and systems.
  • Communicate, plan, prioritize and deliver labeling 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 labeling expertise.
  • Utilise analytical skills to review and develop appropriate content for local labeling documents, based on core content, also recording the decisions made.
  • Work within a framework of internal SOPs and working practices, and external regulatory requirements.
  • Utilise 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.
  • 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.
  • Ensure all actions taken within role follow applicable SOPs and IGs so that high quality delivery of outputs and compliance is maintained.

Education:

  • Life Sciences Degree qualified.

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.