Senior Regulatory Labelling Specialist
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Are you experienced within drug development and motivated by strategic thinking?
The product information (label) is the outcome and conclusion of the entire clinical development. Do you understand the needs of health authorities, health care professionals, payers and patients - and can you realise this knowledge to optimise the label?
The job
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 strat-egies.
- Provide strategic input (opportunities and risks) to development projects.
- Lead scientific and strategic discussions
- Ensure that 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 regulato-ry authorities.
Your qualifications
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.
Your new department
You will be part of a department of dedicated labelling specialists. Our vision is to be strong strategic partners throughout the life-cycle of our products. We are on a journey and you will be part of a department where we learn together.
Contact and application
If you have any questions, please do not hesitate to contact Merete Peder-sen, Head of Labelling Strategy (+45 22700866), Global Regulatory Affairs.
.
About LEO Pharma
At LEO Pharma, we seek passionate, entrepreneurial and solutions-oriented colleagues, and consistently ensure that our people can proactive-ly develop their capabilities and fulfil their potential. Together, we can em-brace the changing healthcare landscape and grasp strategic business op-portunities. The result: life-enhancing products that bring hope to patients living with chronic dermatologic diseases. With a robust R&D pipeline we have a strong vision to become the preferred dermatology care partner.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 8.6.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Ballerup
- Torsdag den 30. september 2021
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