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