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.
