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reference: 4864707

documentId: 4864707

connectionPointId: 7

lastModificationDate: 1534330987323

stillingsbetegnelse: Regulatory Affairs Professional – Labelling

jobbeskrivelse:

Do you want responsibility and major opportunities for learning as part of a super team?

If you have some years’ Regulatory Affairs (RA) experience, and you are looking for an opportunity to accelerate your development, this one-year maternity leave cover could be the chance you have been waiting for. LEO Pharma has set the very ambitious goal to become the world’s preferred dermatology care partner. As a result, we are taking the organisation to the next level and we are expanding our pipeline, which only makes it more challenging and fun to work with Regulatory Labelling.

Key responsibilities

You can look forward to a very diversified job with multiple contacts across the global organisation and to external partners. You will be working closely with the Regulatory Labelling Specialists and will be involved in operational/compliance activities e.g. interface to Artwork/supply chain for implementation of labelling changes, handling of EU SmPC/PIL for CP and MRP/DCP in our documentum system, incl. linguistic review within the CP, KPI (Key Performance Indicators) compliance tracking and deviation handling. In addition, coordinate readability testing of Patient Information Leaflets (PILs). Depending on your background we will strive to tailor the tasks to benefit your competencies and further development as well as the team in general.

 Strong communicator and coordinator with RA experience

You have a Master’s degree within natural science and some years’ experience from Regulatory Affairs. As such, you bring knowledge of guidelines/legislations and awareness of various regulatory environments preferably within the labelling area. In addition, you have a good basic understanding of the life-cycle management of products and the drug development process.

To succeed, you must be very good at collaboration and communication. As part of this you can translate difficult RA language to messages that makes sense to people without regulatory insight. You are a fast learner, structured and you like to be challenged by needs for new knowledge. You have a strong drive for results and you thrive in an ever-changing environment with multiple tasks and deadlines.

 Regulatory Compliance & Operations – your new team

You will join a small and agile team of 5 Regulatory Professionals at the Leo Pharma headquarters in Ballerup, Greater Copenhagen. The team is very well functioning and we work in a friendly atmosphere characterised by knowledge sharing, teamwork and customer focus.

We look forward to receiving your application.

numberOfPosts: 1

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

abstractJV_contact_0:
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positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: LEO PHARMA A/S

source: DK-STAR