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.