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reference: 4925638

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stillingsbetegnelse: Senior Regulatory Labelling Specialist

jobbeskrivelse:

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.

About the department

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.

Your primary tasks will be to:

• Provide strategic input (labelling intelligence, competitor analysis and best practice) to the target product claims and the target product label.
• Ensure the optimal target product label and CCDS for MAAs/BLAs in key markets (EU and US).
• Ensure optimal outcome of life cycle management activities in defined key markets.
• Provide input to creation and updates of the risk management plan. 
• Represent Global Regulatory Affairs in relevant groups/forums e.g. Labelling Management team (LMT), Safety Management Team (SMT) and Regulatory Focus Team (RFT), as relevant.

Qualifications

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.

You ..

• are structured and able to work independently and have a high ability to think strategically
• consistently drive for results even under tough circumstances
• are good at leading and motivating teams and working in global settings
• are perceived as a good team player
• have strong communication skills in oral and written English

Ambitious growth journey

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.

Next step

For further information please contact Merete Pedersen (+45 22 70 08 66).

Please submit your application no later than 18th of January 2019 via http://www.leo-pharma.com.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2423

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: LEO PHARMA A/S

source: DK-STAR