Global Regulatory Affairs Labeling Expert
2 days ago
This role serves as the Global Regulatory Affairs Labeling Expert to the Global Regulatory Team, providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads. The successful candidate will manage multiple assigned projects of increased complexity, including post-marketing projects and those involving 3rd party development.
Key Responsibilities- Act as point of contact for cross-functional teams on global labeling issues, ensuring compliance with all applicable regulations and guidelines.
- Manage updates to Company Core Data Sheets for assigned products, ensuring implementation of CCDS/labeling agreements with licensing partners.
- Prepare documents for review by labeling teams, leading review processes and ensuring appropriate governance for US, EU, and Company Core documents.
- Research applicable Health Authority labeling regulations for products and filings, managing compliance with internal and external guidelines.
- Bachelor's Degree in a scientific discipline; advanced degree preferred.
- 10+ years pharmaceutical industry experience, with 4+ years direct regulatory affairs experience, including CCDS and US/EU labeling experience.
- Experience with country labeling a plus (outside the US/EU) preferred.
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Global Regulatory Affairs Labeling Expert
3 weeks ago
Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full timeJob SummaryDaiichi Sankyo, Inc. is seeking a highly skilled Global Regulatory Affairs Labeling Expert to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs).ResponsibilitiesAct as point of...
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Global Regulatory Affairs Labeling Expert
4 weeks ago
Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full timeJob SummaryDaiichi Sankyo Group is a leading pharmaceutical company dedicated to creating innovative therapies to improve standards of care and address unmet medical needs globally. We are seeking a highly skilled Global Regulatory Affairs Labeling Expert to join our team and provide strategic and operational leadership on product labeling.Key...
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Global Regulatory Affairs Labeling Expert
2 weeks ago
Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full timeJob SummaryDaiichi Sankyo Group is a leading pharmaceutical company dedicated to creating innovative therapies to improve standards of care and address unmet medical needs globally. We are seeking a highly skilled Global Regulatory Affairs Labeling Expert to join our team.Key ResponsibilitiesDevelop and maintain Company Core Data Sheets (CCDS) for assigned...
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Global Regulatory Affairs Labeling Expert
4 weeks ago
Atlanta, Georgia, United States Daiichi Sankyo, Inc. Full timeJob SummaryDaiichi Sankyo Group is a leading pharmaceutical company dedicated to creating innovative therapies to improve standards of care and address unmet medical needs globally. We are seeking a highly skilled Global Regulatory Affairs Labeling Expert to join our team and provide strategic and operational leadership on product labeling.Key...
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