Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
Not Mentioned
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
Highest qualification: University
- 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.