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Regulatory Affairs Leader

2 months ago

London, Greater London, United Kingdom Cpl Healthcare Full time

Job Title: Head of Compliance


Job Type: Full time permanent position


Locations: Remote


Remuneration: Competitive salary and benefits package


At Cpl Healthcare, we are seeking a highly experienced Regulatory Affairs professional to lead our global labeling strategy, operations, and compliance. This is a fantastic opportunity to provide expert regulatory knowledge, providing regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally.


As Head of Compliance, you will be responsible for implementing and managing processes around labeling globally, overseeing labeling activities worldwide for marketed products, creating and maintaining Company Core Data Sheets, and providing strategic advice in the creation of target labeling for development products.



  • Chair cross-functional Global Labeling Committee and Labeling Working Groups to manage the decision-making process for labeling updates to established products
  • Develop, improve, implement and document best-in-class labeling processes, metrics and templates, including influencing stakeholders at all levels
  • Liaise with other Regulatory Affairs functions to ensure labeling updates are submitted and implemented
  • Monitor consistency between local labeling documents and Company Core Data Sheets, and ensure exceptions are documented through standard process
  • Provide strategic interpretations of labeling regulations and guidelines in a range of markets including US and EU
  • Ensure compliance and performance of labeling processes in accordance with departmental KPIs

The ideal candidate will have a minimum of a Bachelor's Degree in a Scientific or Life Sciences Discipline. A PhD is desirable but not a must. Significant Regulatory Affairs Labeling experience, including direct experience with CCDS, Core Product Information and local labeling in a range of markets including US and EU is required. Demonstrates subject matter expertise in labeling and labeling governance, with experience leading labeling professionals and preferably a global labeling team.


This is an excellent opportunity to join a leading business going through a period of growth. This position is a very senior position within the business so will look for a hands-on leader who has experience in all aspects of regulatory labeling for both developing and establishing products.