Our client is a global pharmaceutical company with locations all over the world. This position sits within their newly acquired oncology division.

Client:

• Global European Pharma company
• International team
• Strong oncology portfolio

Your advantages:

• Remote working
• Attractive salary package with extensive benefits
• High amount of responsibility and career growth potential

Position:

• Collaborating with the Regulatory Strategy Leads on projects for labelling activities and providing subject-matter expertise on regulatory labelling requirements
• Independently lead pre- and post-approval labelling activities for assigned products
• Reviewing proposed labelling to ensure consistency with the CCDS and/or reference labelling.
• Review of summary documents such as clinical overviews to ensure the labelling message is consistent with the overall representation of a marketing application.
• Present proposed labelling for global product information documents, including labelling documents in key markets to Senior Management as required for review and approval.
• Performing quality checks to ensure adherence to EU regulatory requirements and formatting guidelines
• Management of labelling changes in Quality Management systems as required
• Working with and managing vendors for translation services (where applicable)
• Manage core labelling documents (CCDS, SmPCs, PILs etc)
• Review and approval of labelling artwork in the Artwork Management System
• Provide labelling support for change control and implementation activities
• Provide labelling contributions for pharmacovigilance periodic reports
• Provide strategic advice for the development of labelling activities
• Lead/contribute to establishment and improvement of working processes and standards as required