Regulatory Affairs Project Manager Labelling Speciialist
|Job Title:||Regulatory Affairs Project Manager Labelling Speciialist|
|Salary:||£45000.00 - £55000.00 per annum|
|Contact Name:||Richard Williamson|
|Job Published:||April 10, 2017 08:20|
A cutting edge Biotech is searching for a Regulatory Affairs Project Manager, Labelling Speciialist. 30% is strategic, 70% is hands-on daily work with any labelling task. The interesting part of the role is to put in place systems and processes for the global product information and drug specific labelling (30%).
- Extensive hands-on experience with end-to-end procedures for generation of drug labels and maintaining compliant drug labels across the world. (managing product information in general).
- Full knowledge of ICH and all aspects of an ICH CTD and in particular CTD Module 1
- Solid knowledge of generation and maintenance of Company Core Data Sheets Company Core Safety Information (CCDS/CCSI)
- Strong knowledge and experience (centrally and nationally) with EU labelling regulations
- Solid experience of managing post approval label changes in key markets (US, EU, UK) and global roll-out.
- Fully experienced with EU QRD templates and requirements around QRD
- Solid understanding of the EU requirements for IDMP and US requirements for Structured Product Labels
- Solid knowledge of EU drug licensing procedures (CEN, DCP, MRP, National )
- Awareness of the concept of EU core-SmPC for biologicals
- Experience of dealing directly with Health Authority assessors.
- Some experience with Clinical Trial Material labelling
- Knowledge of current USA, FDA legislation and guidance for labelling of biological products
For more information please call Richard Williamson 02033273072.
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