Regulatory Affairs Professional – 1 year maternity cover

If you have RA experience including CMC and labelling, and you are looking for a job with major responsibility and equal impact and influence, you don’t have to look any further. By joining LEO you can look forward to a very versatile job where you will work across many aspects of RA, surrounded by skilled and helpful colleagues.


Ensure high quality Life Cycle Management

As part of LEO’ strategy, LEO has divested a number of its Well Established Product. Your main task will be to secure a proper handover to the new owner while still ensure high quality LCM until the MAs have been transferred. Your responsibility covers all aspects, including CMC and labelling. In overview your tasks will be to:

  • Become product responsible within our Well Established Products portfolio, incl. CMC and labelling
  • Ensure high quality life cycle management
  • Handle direct contact to our affiliates and partners in order to fulfil the requirements in the specific markets
  • Be part of several cross functional teams, including our Safety Management Team and Product Support Group


2-3 years’ experience within RA

You have a scientific Master’s degree like M.Sc. in Pharmacy or similar. This is backed by 2-3 years’ experience from working with RA. Your experience also covers CMC, labelling, and in limited extent the clinical and non-clinical part of the dossier. In addition, it is a plus if you have knowledge within eRIMS (electronic Regulatory Information Management System). Because of the variety of the content of the job, it is important that you are able to switch between the roles when needed. As you will be working cross-organisationally in a truly international environment you must be good at English (written and spoken).

As you will join a fast growing organisation you must thrive in an environment characterised by change. This takes an open mind and a positive approach towards tasks, colleagues and partners, also when it takes an extra effort to reach the goal. That’s why you also will need your overview, your structured work approach and your ability to keep a sound perspective in busy days.


Regulatory Affairs WEP – your new department

We are a team of 4 dedicated and open-minded colleagues based at LEO Pharma’s headquarters in Ballerup, Greater Copenhagen. Our focus is to support the market needs with respect to the regulatory requirements from the health authorities. The WEP RA Department is part of Region International.

For more information about the position please contact Senior Manager, Sammy Al-Moalem: SYADK@leo-pharma.com.

We look forward to receiving your application.

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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 5,300 people worldwide.
For more information, visit www.leo-pharma.com.
Application deadline: 24/06/2018

Location: Ballerup, Copenhagen

Job type: Fixed Term Contract

Working hours: Full-time

Working days: Day

Contacts: Sammy Al-Moalem
Mobile: +45 4188 9516