Regulatory Professional for the collection and documentation of regulatory data

As part of our strategy to reach more Patients LEO Pharma is purchasing a global portfolio of dermatology products and we need to integrate this into our Regulatory Affairs operations. To facilitate this integration we are establishing a project team, which you will be a part of. The position is a project assignment planned to last for 12 months. However, good results can lead to a permanent assignment.

Today, 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. And this is where you enter the scene. By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our common quest to become the preferred dermatology care partner improving people’s lives around the world.

Your responsibilities in a challenging position

As part of our Regulatory Data Analyst Team you will be working with the regulatory transfer of a large product portfolio enabling the transfer of marketing authorisations to LEO Pharma and ensuring that we can take over the maintenance responsibilities. The key document in the transfer process will be a registration summary that contains an overview of all approved conditions for the marketing authorisation.  In this position, you will be ensuring that these documents are established and verified for all registrations. Since the product portfolio is already marketed there are a large number of on-going submissions that we need to take over the responsibility for. You will be involved in the verification and updating of our documentation in relation to this task as well.

In overview your primary tasks will be to:

• Interpreting, updating and quality checking the content and format in registration summaries to prepare for third- party data entry into the internal electronic Regulatory Information Management System (eRIMS)
• Verifying information against the archived source data in CTD and NTA format
• Verifying dossiers against requirements either in eCTD format, DocTocs or Paper format
• Updating Registration Summary dossier section to reflect submitted documents
• Translate on-going submission overview to LEO specific format to prepare for third-party data entry into eRIMS system
• Support our sourcing partner responsible for data entry in our eRIMS system
• Ongoing communication with internal and external stakeholders
• Identifying problems and finding innovative solutions

As the task develops there will be opportunities to hold more individual responsibilities as well.



Your qualifications and experience

Candidates with the following skills and background will be preferred:

• Have a relevant academic degree within the pharmaceutical area or other related areas
• Have experience with Regulatory Affairs or related business areas in the pharmaceutical industry
• Knowledge of the CTD format, particularly module 1 and 3 with an understanding of the required documentation for obtaining a marketing authorisation
• Structured and with good analytical and planning skills
• Attention to detail
• Comfortable working with Excel
• Highly motivated to work with Regulatory Affairs

As a person you enjoy working both individually and in a team and you take responsibility for your own tasks. Additionally, you are a strong communicator in English who thrives on working in an international environment with contact to people from different cultures all over the world. We look forward to welcoming you to the team.

Planning and Processes – your new department

Your will be a part of our Planning and Processes department within Regulatory Operations under Regulatory Affairs, Global Development based at the headquarters in Ballerup, Greater Copenhagen. You will report to the Team Manager for the Regulatory Data Analyst Team within Planning and Processes.

We look forward to receiving your application.