Regulatory Submission Manager

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 project management of 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 people with a passion for regulatory affairs to join our team as Regulatory Submission Managers based at LEO Pharma Headquarters in Ballerup, Denmark.

Key responsibilities

As a Submission Manager your overall objective is to plan, manage and facilitate the delivery of submissions within a given product/portfolio. This position is the overall accountable and responsible for project managing individual submissions under an asset, from planning through to case closure. This position involves close collaboration with LEO Phama’s global submission sourcing partner.

Your priority tasks will be:

  • Planning and preparing the regulatory submissions pipeline for drug development and life-cycle management activities. This includes liaising across regulatory content owners inside and outside RA and our sourcing partner
  • Monitoring progress performance via project plans in accordance with LEO’s planning process
  • Authoring and reviewing Module 1 documentation
  • Coordinating the review of published outputs
  • Ensuring that dossiers are proactively submitted and tracked, and that relevant stakeholders are kept informed
  • Coordinating responses to health authority questions and commitments
  • In close collaboration with sourcing partner, ensuring that LEO’s information systems are updated with submissions details, and that documents are uploaded according to compliance and quality standards

Qualifications

We expect you to have:

  • Relevant master degree and/or bachelor degree, or similar work experience
  • Experience working within Regulatory Affairs or related functions such as CMC, Clinical, Pharmacovigilance or Manufacturing within the pharmaceutical industry
  • Knowledge and ideally experience within Submission Management in relation to submission processes
  • Some project management training and experience including communication, collaboration and planning; ability to multitask effectively
  • Experience interacting with different people across the 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 communicator and have the ability to motivate others to adapt to new processes and understand how to build efficient working relationships with both internal and external stakeholders.   

About Regulatory Affairs 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). 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 Jette Bruun Wessel on +45 40 33 93 20 or Alyson Dalby on +45 52 90 45 90.

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: Alyson Dalby
Mobile: +45 5290 4590

Jette Bruun Wessel
Mobile: +45 40339320