Device Manager – Regulatory Affairs
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Ballerup
Can you take LEO Pharma to the next level within global RA device management?
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 into new business areas e.g. biologic treatments. As RA Device Manager you will get the opportunity to define LEO Pharma’s regulatory way forward within the area of devices, focusing on drug-device combinations, all the way from strategy to lifecycle management. You can look forward to influence and impact far beyond the average in a highly exciting job where you can unfold all your skills across people management and RA activities.
Lead the way from strategy to activities and deliverables
Your focus is to lead the device global regulatory activities and deliverables covering LEO Pharma’s established and innovative product portfolios. As such, you are responsible for the regulatory device strategy of submissions as well as management of interactions with regulatory authorities on device issues. The role is combined people management and hands-on work.
To succeed, you must work on two tracks: One is to build knowledge and support in the LEO organization, and one is to develop the RA device framework including strategy/-ies processes and ways of working. Your primary tasks will be to:
Lead, motivate and develop your team Develop an RA device strategy Lead you team to ensure high quality handling of device submission activities Represent RA Device in cross-organizational project teams Ensure global compliance of regulatory requirements Review and provide input on proposed health authority guidance documents on device issues
You will be based at LEO Pharma’s headquarters in Ballerup Greater Copenhagen and can look forward to expectedly 15-20 travel days per year to meet colleagues and partners.
Solid RA experience within devices and people management skills
We are looking for an experienced RA Professional that knows how to lead, motivate and inspire other people. You will need all of capabilities within stakeholder management including your ability to present your ideas and recommendations in an easy understandable way – with your additional understanding of professional and cultural differences. This also takes business acumen and the drive for results needed to turn ideas and plans into actions. As part of an organisations in transformation it is also very important that you can thrive in an environment where the only constant is change, and that you have the courage to make decisions without knowing the full picture. The ideal candidate has;
A university degree within natural science 5+ years RA experience within drug-device combinations 5+ years pharma experience and 3+ years as people manager Solid regulatory device experience on a global level – covering development and maintenance phases for devices and drug-device combinations Solid knowledge of the device regulatory framework Sound understanding of the drug development process, including life-cycle management
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 into new business areas e.g. biologic treatments. As RA Device Manager you will get the opportunity to define LEO Pharma’s regulatory way forward within the area of devices, focusing on drug-device combinations, all the way from strategy to lifecycle management. You can look forward to influence and impact far beyond the average in a highly exciting job where you can unfold all your skills across people management and RA activities.
Lead the way from strategy to activities and deliverables
Your focus is to lead the device global regulatory activities and deliverables covering LEO Pharma’s established and innovative product portfolios. As such, you are responsible for the regulatory device strategy of submissions as well as management of interactions with regulatory authorities on device issues. The role is combined people management and hands-on work.
To succeed, you must work on two tracks: One is to build knowledge and support in the LEO organization, and one is to develop the RA device framework including strategy/-ies processes and ways of working. Your primary tasks will be to:
You will be based at LEO Pharma’s headquarters in Ballerup Greater Copenhagen and can look forward to expectedly 15-20 travel days per year to meet colleagues and partners.
Solid RA experience within devices and people management skills
We are looking for an experienced RA Professional that knows how to lead, motivate and inspire other people. You will need all of capabilities within stakeholder management including your ability to present your ideas and recommendations in an easy understandable way – with your additional understanding of professional and cultural differences. This also takes business acumen and the drive for results needed to turn ideas and plans into actions. As part of an organisations in transformation it is also very important that you can thrive in an environment where the only constant is change, and that you have the courage to make decisions without knowing the full picture. The ideal candidate has;
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 7.11.2019, 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 24. november 2019
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