Senior Regulatory Labelling Specialist

Ballerup, Denmark
Job Description

You will be responsible for driving the global labelling strategy for one or several of our products.

Your primary tasks will be to:

  • Drive the global labelling strategy for one or several of our products, ensuring alignment with the global regulatory and commercial strategies.
  • Provide strategic input (opportunities and risks) to development projects.
  • Lead scientific and strategic discussions
  • Ensure that the optimal outcome of life cycle management activities is reflected in the product information.
  • Provide guidance and support on labelling activities globally.
  • Act as a key stakeholder during labelling negotiations with regulatory authorities.

Desired Skills & Experience

You have a Master’s degree or bachelor within science e.g. pharmaceutics, biomedicine, chemical engineer or a related field, and experience within the regulatory or clinical development area (>5years).

The ideal candidate is curious, proactive, and eager to learn. Collaborative team-players with strong project management and communication skills are highly valued. 

Leo Pharma
New York