Regulatory Affairs Senior Professional – CMC Device
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Make your mark and set the direction – as part of RA CMC
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred medical 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. As a member of RA CMC, you will get the opportunity to work with LEO Pharma’s products approved world-wide and bring innovative products to patients where there is still an unmet need for effective therapy.
Join RA CMC Device and you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
The job
As Regulatory Professional you will represent Global RA with respect to the device constituent part of drug-device combination products. You will be responsible for the strategic regulatory input and to drive the regulatory activities for new and established products. We are working closely with RA CMC and R&D in relevant cross organizational project teams. Here, you ensure the regulatory device deliverables to the device technical file, Module 3, clinical trial applications, and other meeting packages to Health Authorities according to agreed timelines.
As senior professional you will assume the role to guide and set direction within the drug-device combination product area to find the best solutions as far as compliance and how to work across in the organization.
Depending of competencies, you can also take part in projects with our Clinical Departments where we evaluate digital solutions and tools for our clinical studies, providing input on requirements for apps and wearables.
Your qualifications
We are looking for an independent professional with a positive attitude and strategic mindset who will drive and lead the regulatory strategy and associated activities for the device constituent part. You have excellent communication and stakeholder management skills, ability to translate not set in stone regulatory requirements, and build partnerships to meet shared objectives. You thrive in a busy environment, is flexible, and robust to changes.
We expect you to have:
Your new team
RA CMC consist of three departments: Small Molecules, Biologics and Devices. RA CMC Device is a small team of highly engaged and skilled professionals with a great passion for the device regulatory field and the challenging landscape of drug-device combination products. The team is growing and is looking for a new colleague who would like to be part of shaping the drug-device combination area bringing LEO Pharma to the next level.
Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.
By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.
Contact and application
If you have questions, please do not hesitate to contact Cecilie Bengtsen, Manager RA CMC Device at + 45 3170 2129.
. The deadline is June 30th, 2021.
Please note that applications and interviews will be handled on an ongoing basis.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 6,000 people worldwide. For more information, visit www.leo-pharma.com.
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred medical 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. As a member of RA CMC, you will get the opportunity to work with LEO Pharma’s products approved world-wide and bring innovative products to patients where there is still an unmet need for effective therapy.
Join RA CMC Device and you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
The job
As Regulatory Professional you will represent Global RA with respect to the device constituent part of drug-device combination products. You will be responsible for the strategic regulatory input and to drive the regulatory activities for new and established products. We are working closely with RA CMC and R&D in relevant cross organizational project teams. Here, you ensure the regulatory device deliverables to the device technical file, Module 3, clinical trial applications, and other meeting packages to Health Authorities according to agreed timelines.
As senior professional you will assume the role to guide and set direction within the drug-device combination product area to find the best solutions as far as compliance and how to work across in the organization.
Depending of competencies, you can also take part in projects with our Clinical Departments where we evaluate digital solutions and tools for our clinical studies, providing input on requirements for apps and wearables.
Your qualifications
We are looking for an independent professional with a positive attitude and strategic mindset who will drive and lead the regulatory strategy and associated activities for the device constituent part. You have excellent communication and stakeholder management skills, ability to translate not set in stone regulatory requirements, and build partnerships to meet shared objectives. You thrive in a busy environment, is flexible, and robust to changes.
We expect you to have:
- A relevant advanced degree within Sciences (e.g. pharmaceutics, biomedicine, biomedical engineering, biopharmaceutical or related field.
- Preferred experience (5+ years) within Regulatory Affairs medical devices and/or combination products.
- Solid knowledge of regulatory requirements within EU and US.
- Solid experience of handling medical device development documentation as well as Module 3.
- Experience with CFR 820 and ISO 13485 especially Design Control, and ISO 14971 Risk Management.
- Strung business acumen.
- Know how to set direction, drive and lead to reach joint objectives and at the same time a team player who assists your colleagues.
- Clear focus on agreed objectives, even when working with tight deadlines.
Your new team
RA CMC consist of three departments: Small Molecules, Biologics and Devices. RA CMC Device is a small team of highly engaged and skilled professionals with a great passion for the device regulatory field and the challenging landscape of drug-device combination products. The team is growing and is looking for a new colleague who would like to be part of shaping the drug-device combination area bringing LEO Pharma to the next level.
Join our mission to help more people achieve healthy skin
Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.
By joining LEO Pharma you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people’s lives around the world and at the same time create profitable growth.
Contact and application
If you have questions, please do not hesitate to contact Cecilie Bengtsen, Manager RA CMC Device at + 45 3170 2129.
. The deadline is June 30th, 2021.
Please note that applications and interviews will be handled on an ongoing basis.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 6,000 people worldwide. For more information, visit www.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 11.6.2021, 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.
- Apoteker
- Ballerup
- Onsdag den 30. juni 2021
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