Global Regulatory Affairs Lead

2 weeks ago

London, Greater London, United Kingdom Cpl Healthcare Full time

We are seeking an experienced Global Regulatory Affairs Lead to join our team at Cpl Healthcare. This is a fantastic opportunity to provide expert regulatory knowledge and lead global labelling strategy, operations, and compliance.

About the Role

In this role, you will be responsible for implementing and managing processes around labelling globally, overseeing labelling activities worldwide for marketed products, creating and maintaining Company Core Data sheets, and providing strategic advice in the creation of target labelling for development products.

  • Directly oversee and provide strategic and tactical advice for the maintenance and development of CCDS and local labelling deliverables for regulatory filings
  • Chair cross-functional Global Labelling Committee and Labelling Working Groups to manage the decision-making process for labelling updates to established products
  • Design and implement strategy for the creation of a dedicated Global Labelling function
  • Develop, improve, implement and document best-in-class labelling processes, metrics and templates, including influencing stakeholders at all levels
  • Lead development of labelling for products in all stages of development including creation of Target Product Labels
  • Liaise with other Regulatory Affairs functions to ensure labelling updates are submitted and implemented
  • Monitor consistency between local labelling documents and Company Core Data Sheets, and ensure exceptions are documented through standard process
  • Provide strategic interpretations of labelling regulations and guidelines in a range of markets including US and EU
  • Ensure compliance and performance of labelling processes in accordance with departmental KPIs
  • Input into requirements for tools and systems required for the compliant management of labelling documents

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