The Role:To be responsible for tracking and real-time transparency of the approval status of packaging components, in line with the EMA regulatory guidelines. This role...
Working in a team environment the manager will be a subject matter expert on labelling process operations excellence and compliance. They will be accountable for implementing process improvements, and the management and development of SOP's to support inspection readiness. Liaising with the global labelling strategy team the Manager will be accountable for management of the EU linguistic process, readability requirements, packaging and labelling review. The Manager will also support the review of communications and promotional materials for compliance with approved labelling.
Accountable for oversight of the compliance for global labelling processes and supporting associated regional labelling for inspection readiness, including tracking of labelling updates and deviations, maintenance of controlled records for historical, current and ending labelling changes.
Process operations excellence, including SOP and WI development and maintenance.
Review of communications and promotional materials for compliance with approved labelling in Europe.
Management of the EU linguistic process, EU readability requirements, packaging and labelling review and approval
Supporting the development of US, EU, Canada and other regional product labelling, company core data sheets, and for the tracking and archiving of these documents.
The candidate also will be responsible for proofreading and departmental QC work as needed.
This position will report to the Head of Global Labelling.
Skills and Experience required:
BSc. Advanced scientific related degree preferred;
Extensive pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience;
Thorough knowledge of regulations governing drugs and biologics in all phases of development in the EU with a good understanding of regulatory requirements in emerging markets;
Must be strong leader that creates vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way;
Ability to speak other languages would be beneficial.
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 589626
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.