Are you motivated by the opportunity to work in cross-functional teams and drive strategies for product information to authorities, health care professionals and patients? If you bring a strong combination of RA and R&D understanding as well as hands-on experience with driving labelling strategies globally, we might have the right job for you.
The overall focus of the Regulatory Labelling Department is to ensure that LEO Pharma’s product information is in line with the LEO position and strategy for the product and in compliance with authority regulations globally. This includes assessing local deviations to the Company Core Data Sheet (CCDS) for the marketed products as well as interacting with Health Authorities globally on label-related issues. Furthermore, the department has a strong focus on strategic initiatives to improve the way we work e.g. the implementation of the label as the driver for clinical development.
RA Labelling at LEO is divided into two teams - one team responsible for the labelling strategy and content, and one team responsible for compliance and operations. There is a solid collaboration between the two teams. You will be part of the RA Labelling Content team based at LEO Pharma’s headquarter in Ballerup, Greater Copenhagen. The environment is informal with a positive atmosphere and a common drive for results.
You have a natural science degree at minimum a masters level and strong experience within the field of RA labelling and driving global labelling strategies. Preferably you have at least 5-7 years of regulatory experience.
LEO Pharma is on an ambitious growth journey and Global Regulatory Affairs (GRA) plays an important role in supporting the implementation of the LEO vision and growth strategy. We are looking for passionate and innovative people who act with integrity and focus on results.
In Regulatory Affairs we are driven by a common ambition to deliver top quality regulatory work to meet the expectations of our customers no matter if we are working with colleagues in LEO or with Regulatory Authorities.
We look forward receiving your application.
For further information please contact Merete Pedersen (+45 22 70 08 66).
Please submit your application no later than 18th of January 2019 via www.leo-pharma.com.