Senior Regulatory Affairs Professional – RA CMC Devices
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Do you want to be part of the transformation of LEO Pharma?
LEO Pharma has set the highly ambitious goal to become the world’s preferred dermatology care partner. To fulfil this vision, we invest massively in development at all levels and enter new business areas e.g. biologic treatments.
You will join LEO Pharma at a very exciting period in the company’s history, and you can look forward to influence and develop the drug-device combination area.
The job
As Senior RA professional - CMC Device you will represent Global Regulatory Affairs with respect to the device constituent part of drug-device combinations responsible for providing strategic and operational regulatory input for established and new products during life-cycle management and development activities.
Your primary tasks will be to:
Your qualifications
You are degree qualified within science e.g. pharmaceutics, biomedicine, or biomedical engineering with well-founded experience within the regulatory area for medical devices or combination products including solid knowledge of the device/drug-device regulatory framework and design control as well as sound understanding of the drug development process as well as life-cycle management. As a person you thrive in a busy environment; you are flexible and robust to changes. You have a strategic mindset and global perspective, and you have excellent stakeholder management skills; collaborate, communicate effectively, and build partnerships to meet shared objectives.
Your new team
RA CMC Device is a small team with a great passion for the drug-device regulatory field. CMC Device is part of Global RA CMC responsible for the device aspects of LEO Pharma’s products. Our vision is to be a strong strategic and supporting partner throughout the development and life-cycle of our products.
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 27. September 2020. If you have any questions, you are very welcome to contact Cecilie Bengtsen on +45 31702129, RA CMC Device.
About LEO Pharma
At LEO Pharma, we are pioneering together. We help people with skin diseases 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 caring culture and a commitment to helping others. For us, pioneering togetether is about constantly improving and extending 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
LEO Pharma has set the highly ambitious goal to become the world’s preferred dermatology care partner. To fulfil this vision, we invest massively in development at all levels and enter new business areas e.g. biologic treatments.
You will join LEO Pharma at a very exciting period in the company’s history, and you can look forward to influence and develop the drug-device combination area.
The job
As Senior RA professional - CMC Device you will represent Global Regulatory Affairs with respect to the device constituent part of drug-device combinations responsible for providing strategic and operational regulatory input for established and new products during life-cycle management and development activities.
Your primary tasks will be to:
- Provide regulatory device input to the development of global regulatory strategies in collaboration with RA CMC.
- Participate in Life-Cycle Management and product development activities in cross functional project teams, responsible for regulatory compliance of the documentation supporting the device constituent part in relation to changes, authority interactions, and drug-device submissions including Notified Body Opinion.
- Identify and evaluate regulatory issues and impact and liaise with the project team to ensure issues are addressed.
- Increase understanding and impact of the changing regulatory landscape of medical devices and drug-device combination products with stakeholders.
Your qualifications
You are degree qualified within science e.g. pharmaceutics, biomedicine, or biomedical engineering with well-founded experience within the regulatory area for medical devices or combination products including solid knowledge of the device/drug-device regulatory framework and design control as well as sound understanding of the drug development process as well as life-cycle management. As a person you thrive in a busy environment; you are flexible and robust to changes. You have a strategic mindset and global perspective, and you have excellent stakeholder management skills; collaborate, communicate effectively, and build partnerships to meet shared objectives.
Your new team
RA CMC Device is a small team with a great passion for the drug-device regulatory field. CMC Device is part of Global RA CMC responsible for the device aspects of LEO Pharma’s products. Our vision is to be a strong strategic and supporting partner throughout the development and life-cycle of our products.
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 27. September 2020. If you have any questions, you are very welcome to contact Cecilie Bengtsen on +45 31702129, RA CMC Device.
About LEO Pharma
At LEO Pharma, we are pioneering together. We help people with skin diseases 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 caring culture and a commitment to helping others. For us, pioneering togetether is about constantly improving and extending 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
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 2.9.2020, 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.
- Apoteker
- Ballerup
- Søndag den 27. september 2020
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