Regulatory Affairs Professional - Labelling

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Ballerup

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 14-month 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. You will get the opportunity to make a significant difference for people with serious skin diseases all over the world.

The job



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.

  • project manage safety/labelling variations,
  • create/drive the regulatory labelling packaging strategy,
  • interface to Device unit,
  • 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. EU CP linguistic reviews,
  • KPI (Key Performance Indicators) compliance tracking and deviation handling,
  • 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.

Your qualifications



You have a Master’s degree or bachelor within natural science and at least 3 years’ experience from Regulatory Affairs. As such, you bring knowledge of guidelines/legislations and awareness of various regulatory environments preferably within the labelling area.

You have a good basic understanding of the life-cycle management of products and the drug development process. Furthermore, good project management experience is required.

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.

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.

Join our mission to help more people achieve healthy skin



Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what Leo Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.

By joining Leo Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.

Contact and application



If you have questions, please do not hesitate to contact Ann Norén, Head of RA Labelling Operations, at + 45 2557 8063.

. We look forward to receiving your application. Send your application to us as soon as possible and no later than Sunday 23 January 2022 as we will be conducting interviews on an ongoing basis.

Applications will be reviewed as from 04 January 2022.

About Leo Pharma



Leo Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, Leo Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. Leo Pharma is headquartered in Denmark and employs around 6,000 people worldwide. For more information, visit www.leo-pharma.com.


Information og data

Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i Ballerup.

Jobbet er oprettet på vores service den 21.12.2021, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Apoteker
  • Ballerup
  • Søndag den 23. januar 2022

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