id: NTAyMjUzOCA3

reference: 5022538

documentId: 5022538

connectionPointId: 7

lastModificationDate: 1564057813073

stillingsbetegnelse: Regulatory Lead to pioneer development project

jobbeskrivelse:

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.

For more information

Please contact Sr. Director, Regulatory Affairs International, Nina Christiansen at +45 25518700, or
Sr. Director, Established Portfolio Management, Simon Bolvig at +45 72263093.

We look forward to receiving your application no later than August 11th 2019. Interviews will be held on an ongoing basis.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2421

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