The Role:Responsible for the coordination of all First Registrations, Renewals, Tenders, Response to questions and Site Registrations submissions. Ensuring delivery to agreed timelines and in...
Maintain EU SmPCs for marketed products and EU PILs for initial approvals and updates to marketed products approved by CP and MRP in the EU/EEA.
Working closely with the Global Labelling team within EU, US Western Europe to ensure documentation and coordination for the EU SmPCs and EU PILs align with global processes and compliance.
- Creates/updates the EU PIL in line with the draft SmPC, EU labelling requirements and language required for patient centric texts. Reviews final draft PIL for submission. Works closely with the GL US team to ensure alignment with the agreed global labelling strategy.
- Supports the Labelling Strategist and WE Product Lead to ensure that the revisions to the SmPCs are aligned with the CCDS for initial approval of new products or new indications, allowing for differences based on MOH feedback.
- For marketed products, reviews the CCDS revisions and redlines the EU SmPC accordingly.
- Supports WE Product Leads in the review of Assessment Reports for changes requested by authorities and may redline the draft SmPC for discussion at LST/ELC under the direction of the WE Product Lead.
- Maintains accurate files of labelling change history and associated documents, under the direction of the EU Global Labelling Lead.
- Works with Labelling Operations and the Global Labelling Strategist to ensure quality documents are internally maintained and submitted to EMA.
- Required education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology or related life science
- Experience with pharmaceutical industry preferred
- Past experience in Regulatory with experience in prescription drug or device product labelling or equivalent within the pharmaceutical industry
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.