LEO Pharma

Regulatory Professional - Submission Management

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 someone with a passion for regulatory affairs to join our team as a Regulatory Submission Manager based in LEO Headquarters in Ballerup, Denmark. Start as soon as possible.

 

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, under the guidance of a senior colleague. This position involves close collaboration with LEO Pharma’s global submission sourcing partner.

 

Your priority tasks will be:

  • Planning and preparing the regulatory submissions pipeline for drug development and life-cycle maintenance 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 Pharma’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 Pharma’s regulatory information management system is updated with submissions details, and that documents are uploaded in the document management system according to compliance and quality standards

 

Qualifications

We expect you to have:

  • Relevant master degree and/or bachelor degree, or similar work experience
  • Experience with or knowledge of Regulatory Affairs or related functions such as CMC, Clinical, Pharmacovigilance or Manufacturing within the pharmaceutical industry
  • Some project management experience including communication, collaboration and planning; 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 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 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 in 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 Wessel on 40 33 93 20

Please submit your application and CV in English as soon as possible but no later than
5 November 2018, as we will be reviewing incoming applications on an on-going basis.

We look forward to receiving your application.

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Region:

  • Region Hovedstaden
  • Region Sjælland

Job type:

Permanent

Working hours:

Full-time

Application deadline:

05/11/2018

Location:

Ballerup, Greater Copenhagen

Contacts:

Jette Bruun Wessel

Mobile: +45 40339320

Company homepage:

http://www.leopharma.com

Office address: