The Role:To obtain, manage and maintain product Marketing Authorisations and Clinical Trial Authorisations (where applicable) in line with business goals and legal requirements. Under the...
The EU Labelling Contractor has assigned products for which they are responsible for End to End labelling. Therefore, maintains EU SmPCs for marketed products and EU PILs for initial approvals and updates to marketed products approved by the Centralized or Mutually Recognised Procedure in the EU/EEA. In addition is responsible to input content and layout per EMA requirements for mock-ups and production artwork.
- 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.
- QC SmPC/PIL updates as required.
- For assigned marketed products, reviews the CCDS revisions and redlines the EU SmPC accordingly.
- Participates in Labelling Subteam meetings during labelling negotiations for assigned products. Redlines the EU SmPC and EU PIL with agreed language as determined by the LST.
- Works to ensure quality documents are internally maintained and submitted to EMA.
- Opens commodity workflows in the artwork system for Assigned products, leads mock-up discussions and review/approval for assigned products. Also reviews/approves EU production artwork where required.
- Leads readability testing strategy for assigned products.
- Supports linguistic review translation co-ordination when required.
- Supports product launches where required for EU labelling function.
- Required education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology or related life science
- Experience working in a complex and matrix environment
- Excellent organizational and time management skills
- Strong communication both oral and written and proactive negotiation skills
- Experience with pharmaceutical industry required
- Past experience in Regulatory with experience in prescription drug product labelling and artwork/packaging
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.