Submission Process Manager

Can you handle a full responsibility for driving and improving the regulatory submission process?

Are you looking for a challenging position in a fast growing and successful company? Do you have flair for and interest in process, project and performance management and LEAN and want to work in Regulatory Affairs, then now you have the opportunity to take on an exciting role as a Submission Process Manager in LEO HQ where the submission process is used for LEO products marketed in more than 120 markets.

Key responsibilities

As a Submission Process Manager, your overall objective is to ensure continuous development, improvement and implementation of the submission processes to enable even better performance in Global Regulatory Affairs. Your primary tasks will be to:

  • Be responsible for the submission process flows and standard frameworks
  • Establish, implement, and optimize the submission process both at LEO HQ RA and Local RA and at External Regulatory Service Provider
  • Ensure that descriptions and tools are implemented and that operations happen as per the defined process
  • Drive continuous improvement projects in collaboration with our External Regulatory Service Provider, RA Submission Management, LEO HQ and Local RA functions
  • Represent submission process internally and externally and drive alignment between submission process and other processes/systems
  • Train people, both internal and external, in submission process in order to ensure a process oriented culture
  • Implementing process KPIs and follow up on performance with employees and management


Qualifications

We expect you to have:

  • Scientific Master degree or similar working experience
  • Experience working with processes, optimization and LEAN
  • Experience within project management or strong desire to develop and take on the role as a project manager
  • Preferably, but not a requirement, working experience  in Regulatory Affairs, pharma or administrative functions
  • Preferably you have also worked with external service providers

People know you for being proactive and result-driven, as well as for your ability to take ownership. You are great at analysing and finding solutions, while being open to new ideas and inputs from others. You have a good eye for details without losing the view on the big picture. You are an excellent collaborator and communicator and have ability to motivate others to adapt to to new processes and understand how to build efficient working relationships with both internal and external stakeholders.    

About RA Submission Management

The RA Submission Management Department consists of approx. 35 dedicated and skilled colleagues across 3 teams (2 in Denmark and 1 in Ireland). The position is within the RA Submission Management & Process Team, consisting of 11 people, located at headquarters in Ballerup DK. As part of Global Regulatory Affairs we are responsible for regulatory submissions on a global scale from early development throughout life-cycle management requiring efficient processes and solid collaboration with several different stakeholders within HQ and affiliates.  

Contact and application deadline

For further information, please contact Manager Jette Bruun Wessel on +45 40 33 93 20

Please submit your application no later than August 6, 2017.


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 4,800 people worldwide.
For more information, visit www.leo-pharma.com.
Application deadline: 06 Aug 2017

Location: Ballerup, Greater Copenhagen, DK

Job type: Permanent

Working hours: Full-time

Contacts: Jette Bruun Wessel
Mobile: +45 40339320