Global labelling & Compliance Manager
Overview
At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.
Job Purpose
Join our dynamic team as a Global Labelling & Compliance Manager !
Lead the charge in shaping and maintaining our global labelling strategies while ensuring compliance across the board. This role offers a unique blend of strategic leadership and compliance oversight, working cross-functionally with experts to drive our products’ success worldwide.
If you’re passionate about regulatory affairs and ready to make a global impact, this is the opportunity for you!
Responsibilities
- Guide CCDS Working Teams: Lead the creation and maintenance of global CCDSs/dCCDSs, ensuring alignment with labelling strategies, whilst adhering to timelines.
- Coordinate Meetings: Schedule and arrange CCDS WT and GLC meetings for endorsement and updates.
- Communicate Approvals: Author and disseminate approved CCDSs/dCCDSs to internal stakeholders and licence partners.
- 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.
Qualifications
- Bachelor's degree (science discipline preferred). Further relevant qualification desirable.
- Experience in the pharmaceutical industry, ideally including working knowledge and experience of regulatory labelling.
- Ability to understand regulatory and technical concepts and requirements.
- Good working knowledge of Microsoft Office required.
- Prior experience with assessing change controls and/or RIM system reporting.
Join us and play a pivotal role in shaping our global labelling strategies and ensuring compliance across the board!