LEO Pharma

Regulatory Professional – Development 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 Professional based in LEO Headquarters in Ballerup, Denmark. This is a permanent position. The expected start date is as soon as possible.

 

Key responsibilities

In this position you will be working with both development project and life-cycle submission activities. As a Regulatory Professional your overall objective is to plan, manage and facilitate the delivery of submissions within a given project/product/portfolio. This position is the overall accountable and responsible for project managing individual submissions under an asset, from planning through to case closure.

Your priority tasks will be:

  • Manage and keep an overview of the Regulatory Submission Pipeline for drug development and life-cycle submission activities. This includes liaising across regulatory content owners inside and outside RA and our sourcing partner
  • Plan, prepare, and drive the submission strategies
  • Take active part of the regulatory cross-functional focus team within a portfolio representing Submission Management and acting as counterpart to other parts of Regulatory Affairs (RA) working within the same portfolio (e.g. RA CMC, RA Labelling and Regulatory Affairs Project)
  • Monitor progress performance on the Regulatory Submission Plans and communicate goals, status, challenges, opportunities, risks as well as potential solutions to relevant stakeholders
  • Authoring and reviewing Module 1 documentation
  • Coordinating the review of published output
  • 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

As the perfect match we expect you to have:

  • Relevant scientific degree
  • Solid experience from Regulatory Affairs working with regulatory submissions of new MAAs and life-cycle activities globally
  • Solid project manager skills and experience from project managing regulatory activities/submission pipelines
  • Good understanding of regulatory application components in Modul 1-5
  • A strong drive for results and especially good communication, collaboration, planning and prioritisation skills
  • Experience working in a global setting with cultural differences and different internal and external contributors
  • Fluent English language skills

People know you for being proactive and result-driven, your ability to take ownership, as well as persistence and being robust when required. You are curious and great at analysing and finding solutions and spotting opportunities, while being open to new ideas and inputs from others. You are structured and have the big overview and at the same time a good eye for the details. You are an excellent collaborator and communicator and have 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. 38 dedicated and skilled colleagues across 3 teams (2 in Denmark and 1 in Ireland). This position is located in headquarter 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 Marian Bohn on +45 31 41 39 71.

Please submit your application and CV in English as soon as possible but no later than 31 October 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:

31/10/2018

Location:

Ballerup, Greater Copenhagen

Contacts:

Marian Mosekjaer Bohn

Mobile: +45 31413971

Company homepage:

http://www.leopharma.com

Office address: