My client, an expanding Clinical Research Organisation are currently seeking to recruit a Senior Director of Regulatory Affairs to join their Regulatory team. This position...
My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Labelling Project Manager to be based in their offices in Berkshire until the end of 2019.
The EU Labelling Contractor works on the label alignment project for the EU SmPC (&PL) reviews. They will perform reviews of the English SmPC against the Core Datasheet and co-ordinate affiliate reviews, consolidate findings and work with the functions and teams associated with the project to deliver results.
In addition the Project Manager will support other Label team staff with EU labelling products for End to End labelling. Therefore, support maintenance of 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. Also responsible to manage labels/PI annexes in the content management system and review/approve artwork from the EU for accuracy.
- Support label alignment/full QC project as directed by Team lead.
- QC SmPC/PIL updates as required for updates to marketed product labelling.
- 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 SGL US team to ensure alignment with the agreed global labelling strategy.
- Reviews the CCDS revisions and redlines the EU SmPC accordingly.
- Participates in Labeling Subteam meetings during labelling negotiations. Redlines the EU SmPC and EU PIL with agreed language as determined by the LST. (The LST meeting will be chaired by GL US).
- Works to ensure quality documents are internally maintained and submitted to EMA.
- Reviews/approves EU production artwork where required.
- Supports readability testing strategy.
- Supports linguistic review translation co-ordination.
- Processing/storage (archival) of Summary of SmPCs, PILs and Labels ensuring they are compliant to internal requirements for publishing such as titles in GLS, native content, versions and meet the requirements for the EMA such as bookmarking, and document properties.
- Required education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology or related life science
- Experience working in a complex and matrix environment
- Strong communication both oral and written and proactive negotiation skills
- 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: Natasha.Rollason@SRG.co.uk or +441753 589673