The Role:Regulatory Strategist EU above Country Reports to EU Regulatory Lead Job focus will support the EU regulatory lead, working with global teams with input...
Manage the coordination, tracking and oversight of the EU centralized and mutual recognition EN label translations into European languages per the required regulatory approval and also support the Submissions Management Translations Lead in communicating and championing the business process to affected stakeholders, and may participate in continuous improvement activities.
- Works with the Labeling Operations Specialist (LOS) and Above Country strategist to obtain the internally approved EN label, submission type and summary of changes.
- Owns the forecast spreadsheet, actively seeking updates and clarity to provide status update to PCOs; proactively works with the PCOs to provide upcoming translations and timelines.
- Provides draft GDMS links to the PCOs for each country language and lifecycle within the system once HA Approved.
- Ensures that all labeling translation jobs initiated within GDMS have been picked up by the designated Labeling Translations Vendor and that the resulting translations are delivered per the agreed SLA timeframes.
- Monitors internal tracking systems to ensure that the status of every labeling translation is visible and overseen through to completion and entered into the correct location in the document management system.
- Suggests/advises the team which label translations should occur 'at risk', liaises with the Translations vendor to progress the translations accordingly; Trouble shoots vendor issues as required.
- Ensures CHMP opinion is communicated to PCOs and the Translation Vendor so that the appropriate actions are taken and deadlines are re-confirmed
- Proactively uses Eudralink Account to monitor local HA responses and co-ordinate actions and issue resolution with PCOs.
- Collates and completes the EMA QRD forms for WRS to review and use for submission.
Bachelor's degree or equivalent in Life Sciences.
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.