Regulatory Lead to pioneer development project

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Ballerup

Can you find solutions to new and unknown challenges?

If you bring profound knowledge across RA and you are looking for a unique challenge for your further career, is here a great opportunity for you. LEO Pharma has set the very ambitious goal to become the world’s preferred dermatology care partner and to help 100+ million patients in 2025. To make this come true we want to develop LCM products specifically targeted countries outside and without dependency on EU and the US, e.g. China, Russia, GCC and Brazil. That is why we need you and all of your pioneering spirit as part of our small and agile core team. The potential is just as huge and exciting than the challenges ahead of us.

Overall responsible for regulatory strategies and deliverables via external partner

Your overall objective is to bring a new product to the market by 2025. You and the development team will focus on developing new products based on existing APIs in collaboration with external partners that you will help to identify, select and manage. As Regulatory Lead you will be responsible for regulatory strategies and deliverables via the external partner. As such, good vendor management will be critical for your success. Your primary tasks will be to:

  • Contribute to identify and select external development partners
  • Develop regulatory strategies – in close dialogue with external partner(s)
  • Ensure on-going progress according to plans – vendor management
  • Ensure high quality and solid documentation – vendor management
  • Deliver stage gate reports and related project communication
  • Contribute to development of project business plans and recommendations


  • As part of a small team you will work at all levels from high-level strategy to hands-on operational tasks. Ideally, you will be based at our HQ in Ballerup, Greater Copenhagen but if you are our perfect match, we are open for a dialogue regarding alternative solutions.

    10+ years’ of international RA experience

    We are looking for a pioneer that thrives on breaking new land. If that person is you, you are generally very curious and you have the courage to enter unknown paths and the ability to find the most feasible regulatory pathway. Additionally, you can see opportunities and possible solutions when facing tough challenges, and you have the persistency to keep on going. Your professional skillset comprises:

  • A natural science degree
  • 10+ years’ experience from working with RA across several functions
  • Experience from working with regulatory authorities in international markets
  • A proven track record of applications without dependency on approvals in the EU, the US, Canada and Australia
  • A good understanding of drug development and LCM
  • Project management experience


  • Your new team

    You will be part of our dedicated development portfolio team together with the Senior Director and a Senior CMC Scientist. Our focus is to apply a biotech mindset where courage and can-do-attitude goes hand in hand with intelligent risk assessment – topped with the positive LEO culture of mutual trust, respect, helpfulness and room for having a good time together.


    Information og data

    Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".

    Arbejdsstedet er beliggende i Ballerup.

    Jobbet er oprettet på vores service den 12.7.2019, 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.
    • Projektleder
    • Ballerup
    • Søndag den 11. august 2019

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