About this role

Supports cross-functional, end-to-end non-US/Central EU global labeling processes
Assesses labeling changes for differences in meaning and emphasis
Helps resolve issues between the countries and Product Care, Quality and Supply Chain
Ensures consistent communication to the regions and countries regarding updates to CCDSs
Leads the assessment and review of proposed exceptions between the CCDS and the MOW labeling
Remains up to date with the global labeling requirements
Represents Global Labeling in internal and external meetings

University degree in Life Sciences or related Pharmaceutical field (e.g., Chemistry, Engineering)
Biotech/pharmaceutical industry experience
Knowledge and understanding of principles of regulatory requirements relevant to drug development
Demonstrated problem-solving ability able to analyze risk
Must work well with others and within global teams
Organizational skills to interact seamlessly internally and externally on regulatory compliance matters
Proficient regulatory knowledge including an understanding of scientific concepts within labeling

Manager, Labeling Operations

Key skills