Regulatory Associate Submission Manager - Pharmaconomist

Do you want to make a difference in a challenging position?

Are you looking for a challenging position in a fast growing and successful company? Do you want to be part of a department with focus on portfolio and global regulatory submissions, supporting business opportunities, enabling regulatory compliance and regulatory operational excellence? Do you thrive in an environment of global and cross functional collaboration, bringing out the best in your colleagues and partners around the world?

We are looking for someone with a passion for regulatory affairs to join our team as a Regulatory Associate Submission Manager based at LEO Pharma's headquarters in Ballerup, Denmark. This is a permanent position.

Key responsibilities

As Associate Submission Manager your overall objective is to plan, manage and facilitate the delivery of cross product/portfolio activities and submissions. Further this position will be part of one or two teams/portfolios supporting the development and life cycle activities. This position involves close collaboration with colleagues here in Ballerup, Local Regulatory Affairs and LEO Phama’s partners.

Your priority tasks will be:

  • Plan, preparing and dispatch the submissions of cross product submissions like site renewals
  • Handle responses from health authority making sure regulatory approval is obtained of site renewals
  • Responsible for cross product/portfolio activities like processes for the samples and certificates
  • Coordination of cross product submissions
  • Support a product portfolio and development projects with e.g. review of documents and creating publishing table of content
  • Coordinating the review of published outputs
  • In close collaboration with sourcing partner, ensuring that LEO’s information systems are updated with submission details, and that documents are uploaded according to compliance and quality standards

Qualifications

We expect you to have:

  • Education as pharmaconomist or similar work experience
  • Some experience with or knowledge of Regulatory Affairs or related functions such as CMC, Clinical, Pharmacovigilance or Manufacturing within the pharmaceutical industry
  • Communication, collaboration and planning skills; able to multitask effectively
  • Experience interacting with different people across an organisation and across cultures
  • Fluent English language skills

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 understand how to build efficient working relationships with stakeholders.   

About Regulatory Affairs Submission Management

The RA Submission Management Department consists of approx. 38 dedicated and skilled colleagues across 3 teams (2 in Denmark and 1 in Ireland). These positions are located at headquarters in Ballerup, Denmark. 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 headquarters and affiliates. 

Contact and application deadline

For further information, please contact Manager Marian Bohn on +45 31 41 39 71.

Please submit your application no later than 3 June 2018.

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: 03/06/2018

Location: Ballerup, Greater Copenhagen, DK

Job type: Permanent

Working hours: Full-time

Contacts: Marian Mosekjaer Bohn
Mobile: +45 31413971