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Senior Regulatory Labelling Specialist

Are you passionate about clinical development and regulatory strategies?

Are you motivated by the opportunity to work in cross-functional teams and drive strategies for product information to authorities, health care pro-fessionals, payers and patients? Do you have experience with clinical development and with driving labelling strategies globally? And are you a team player? Then we might have the right job for you.

In this job you will be responsible for driving the global labelling strategy for one or several projects and products, ensuring alignment with the global regulato-ry and commercial strategies.

Your primary tasks will be to:

  • Drive the development of the optimal target product label and Company Core Datasheet (CCDS) for MAAs/BLAs in key markets.
  • Provide strategic and scientific input (labelling intelligence, competi-tor analysis and best practice) to the target product label and to the design of the clinical development programme to support the label.
  • Act as a key stakeholder during labelling negotiations with regulatory authorities.
  • Ensure optimal outcome of life cycle management activities in defined key markets with the aim of optimising labels.
  • Represent Global Regulatory Affairs in relevant project teams, e.g. safety management team and teams responsible for development of target product claims.

Your qualifications

You are degree qualified within science e.g. pharmaceutics, biomedicine, chemical engineer or a related field, and wellfounded experience within the regulatory or clinical development area.

In addition you:

  • Understand the entire drug development process and how the development program will impact the final label.
  • Understand the science and data relevant for the label.
  • Know of strategies to optimise labels during development and life-cycle management of products, including the utilisation of real world evidence and patient reported outcomes. 
  • Have expert knowledge of various regulatory environments, including but not limited to EU and US.
  • Have excellent stakeholder management skills; collaborate, manage experts and build partnerships to meet shared objectives.
  • Are a team player - proactive, curious and eager to learn.

Your new team

You will be part of a team of dedicated labelling specialist. Our vision is to be strong strategic labelling partners throughout the life-cycle of our products. We have focus on various strategic initiatives to improve the way we work e.g. the implementation of the label as the driver for clinical development. We are on a journey - and you will be part of a team with high focus on knowledge sharing and learning.

Contact and application

We will review applications on an ongoing basis so please don’t hesitate in sending us your application along with a short cover letter via our website. The deadline for application is 20. September 2020. Should you have any questions, please call Merete Pedersen on +45 22700866.

We look forward to receiving your application.

About LEO Pharma

At LEO Pharma, we are pioneering together. We help people with skin dis-eases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration and curiosity. We are at the forefront of science in developing new medicines for dermatology. Each one of us at LEO Pharma can make a real impact in our everyday work. Together, we explore new ideas and make them happen. We do this through mutual respect and a shared sense of purpose, rooted in our car-ing culture and a commitment to helping others. For us, pioneering togeth-er is about constantly improving and extefnding what’s possible for each other, our company, and our patients.

LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. In 2019, the company generated net sales of DKK 10,805 million. Read more at leo-pharma.com


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