Global Labeling Manager

Description

• Maintaining regulatory compliant, competitive and up-to-date global labelling documents for assigned products, leading the ELTF to align on labelling strategy, labelling course of action and text.
• Representing Global Labelling in relevant sub-teams, researching and providing input about labelling topics across different markets, the competition, and regulations.
• Contributing to the creation of high-quality documents supporting changes to the CDS, USPI, EU SmPC and leading responses to labelling-related Health Authority queries.
• Leading the interaction with Country Organizations to ensure the timely implementation of labelling changes in local product information and ensuring consistency and compliance with the CDS.
• Representing Global Labelling during audits and inspections, as required.

Qualifications

• Bachelor’s or advanced degree in life science or pharmaceutical sciences.
• Experience in global labelling (incl. US and EU), or in related areas of the pharmaceutical industry or Health Authorities.
• Strong interpersonal, project management, communication, negotiation and problem-solving skills.
• Ability to lead cross-functional teams in a complex, matrixed work environment.
• Compliance and Quality approach.