Pharmaceutical Compliance Manager

6 days ago


Marlow, United Kingdom Kyowa Kirin International Full time
Job Overview
The role of Global Labelling & Compliance Manager is a unique opportunity to shape and maintain our global labelling strategies while ensuring compliance across the board. This position offers a blend of strategic leadership and compliance oversight, working cross-functionally with experts to drive product success worldwide.

About the Role
This position is responsible for leading the charge in shaping and maintaining our global labelling strategies while ensuring compliance across the board. The ideal candidate will have experience in the pharmaceutical industry, ideally including working knowledge and experience of regulatory labelling. They will be able to understand regulatory and technical concepts and requirements, as well as have good working knowledge of Microsoft Office required.

Key Responsibilities
  • Support Labelling Working Groups: Assist in incorporating CCDSs/dCCDSs into local/regional product information, ensuring alignment with internal strategies and regulatory requirements.
  • Review Changes: Evaluate proposed changes to local/regional product information, identifying and addressing meaningful differences.
  • Compliance Oversight: Run semi-automated reports to monitor and ensure timely safety labelling variations and overall global compliance.
  • Collaborate on Reporting Needs: Work with Regulatory Operations and external vendors to maintain and develop reporting systems.
  • Additional Duties: Review and revise SOPs, manage labelling operations, and prepare for audits and inspections related to CCDS and labelling management.

What You Need to Succeed
  1. Bachelor's degree (science discipline preferred).
  2. Experience in the pharmaceutical industry, ideally including working knowledge and experience of regulatory labelling.
  3. Ability to understand regulatory and technical concepts and requirements.
  4. Good working knowledge of Microsoft Office required.


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