LEO Pharma

Do you want to be working on one of LEO Pharma’s strategic established portfolios?

Senior Regulatory Project Manager - Regulatory Affairs Focus Team

Do you have several years of regulatory experience across the non-clinical and clinical areas, as well as project management of global regulatory submissions, and are you looking for an opportunity to be part of one of LEO Pharma’s strategic established portfolios, this could be the position for you! You will get the chance to personally impact the regulatory strategies and deliverables and by this positively influence the goal of treating thrombotic patients.

LEO Pharma is on an exciting journey

LEO Pharma is stronger than ever with a growing global presence, a dedicated work force of more than 5,000 specialists and a strong pipeline of unrivalled pharmaceutical products within dermatology and thrombosis. In 2017, LEO Pharma helped more than 80 million patients, and laid out a new ambitious strategy towards 2025, with a clear direction towards global leadership in medical dermatology, while still continuing our investment in our thrombosis business.

As Senior Regulatory Project Manager in our Regulatory Affairs Focus Team you will chair the cross-departmental RA focus team with members from RA CMC, Labelling, Submission Management and colleagues from our global affiliates. With you as the main driver, the team will prepare, drive and implement the regulatory life-cycle strategies.

Your key responsibilities will be to:

  • Lead the regulatory focus team for LEO Pharma’s strategic established portfolio within Thrombosis
    • Prepare Global Regulatory Strategies and ensuring implementation hereof
    • Ensure business perspective across functions and high regulatory quality
    • Set direction, motivate, building trust and ensure commitment among the team
    • Drive submissions – in collaboration with other regulatory functions e.g. Submission Management covering life-cycle activities incl. work-sharing procedure, variations, aggregated safety reports etc.
    • Plan and drive authority interactions
    • Ensure issue management, if plan is deviated
    • Ensure best use of available resources
    • Act as subject matter expert within non-clinical and clinical
      • Deliver knowledge concerning non-clinical and clinical related issues, and upcoming non-clinical and clinical variations
      • Provide the regulatory input to clinical and non-clinical strategies  and documentation
      • Review of proposals for Investigator-Initiated Studies and Non-Interventional Studies
      • Regulatory responsible for documents like regulatory summaries and overviews

Your many international contacts will give you the opportunity for major influence and impact across teams and stakeholders and provide you with a thorough understanding of the business.

+5 years’ experience within RA – in particular in the non-clinical and clinical area

You have a natural science degree at minimum a master’s level and at least 5 years’ experience within Regulatory Affairs. Your career has provided you with solid knowledge of global regulatory documentation, especially in the non-clinical and clinical area, as well as regulatory project management skills. At the same time you are a strong strategic thinker.

You enjoy working globally and have experience working with other cultures. You have the communication and stakeholder management skills needed to create regulatory awareness. Related to this you can tailor your messages to the receivers of the information at hand. To succeed, you must also be able to lead, inspire and motivate members of your teams that do not report to you.

About Regulatory Affairs Focus Team

You will join an established team of 10 Regulatory Project Managers. Our goal is to build a culture centred on knowledge sharing, helpfulness and the ability to learn from hands-on experiences. We see you as an important contributor in making this vision come through.

We are based at the LEO headquarters in Ballerup, Greater Copenhagen. We are part of the Global Regulatory Affairs organisation counting approx. 150 people across the globe that shares the ambition to deliver top quality across projects and assignments.

Further information and application deadline

If you have any questions in relation to the position, you are welcome to contact Senior Manager Maiken Gy Kongstad on phone: +45 30 100 481 or on email: OTYDK@leo-pharma.com

Deadline for submitting your application is Sunday July 29th.

We look forward to receiving your application.

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Ballerup, Greater Copenhagen, DK


Maiken Gy Kongstad

Telephone: +45 30100481

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