Professional – Regulatory Processes & Compliance
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Take our Global Regulatory Affairs compliance to the next level
LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. In Global Regulatory Affairs, we are changing our operating model, introducing a new global partner and simplifying our quality framework in a global set up. This is where you enter the scene with all of your quality mindset.
In Regulatory Processes & Compliance you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
Securing and supporting a quality setup that is easy to use and easy to maintain and thereby facilitate compliance across Global Regulatory Affairs.
Your primary tasks will be:
You will need to seek innovative and simple solutions, embrace change and have a strong drive for the most optimal results. As part of a support team you must like to help other people and do it with due respect for professional and cultural differences. As part of this, you can communicate in an easy understandable and motivating way that makes your audience understand and support your recommendations.
You will join our team of 4 at LEO Pharma in Ballerup, Greater Copenhagen with a team member in Dublin Ireland. Together, we work with our RA Quality Management System (QMS) with the ambition to make it best-in-class.
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.
If you have questions, please do not hesitate to contact Lis Lønager Boesen, Head of Regulatory Processes & Compliance, at + 45 53614153.
. The deadline is 16 th of July 2021.
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 dermatology care partner – and that is why we need you. In Global Regulatory Affairs, we are changing our operating model, introducing a new global partner and simplifying our quality framework in a global set up. This is where you enter the scene with all of your quality mindset.
In Regulatory Processes & Compliance you will get the opportunity to make a significant difference for people with serious skin diseases all over the world.
The job
Securing and supporting a quality setup that is easy to use and easy to maintain and thereby facilitate compliance across Global Regulatory Affairs.
Your primary tasks will be:
- Develop & Maintain Regulatory Training Matrix
- Manage Changes, Deviations and Non-Conformities including CAPA handling
- Manage GxP Supplier list
- Develop and offer/conduct adequate training of RA colleagues
- Ensure Process interaction with stakeholders and subject matter experts
- Drive and co-ordinate Process Group Work
- Manage RA processes – facilitate, write procedures, draw process flows
Your qualifications
- Master’s degree within science, e.g. pharmaceutical or related
- +3 years’ experience within Regulatory Affairs Globally or R&D QA with GxP experience
- Understanding of the regulatory and compliance framework
- Experience with global process management
- Understanding of RA contribution to the drug development as well as life-cycle management
You will need to seek innovative and simple solutions, embrace change and have a strong drive for the most optimal results. As part of a support team you must like to help other people and do it with due respect for professional and cultural differences. As part of this, you can communicate in an easy understandable and motivating way that makes your audience understand and support your recommendations.
Your new team
You will join our team of 4 at LEO Pharma in Ballerup, Greater Copenhagen with a team member in Dublin Ireland. Together, we work with our RA Quality Management System (QMS) with the ambition to make it best-in-class.
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 Lis Lønager Boesen, Head of Regulatory Processes & Compliance, at + 45 53614153.
. The deadline is 16 th of July 2021.
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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
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.
- Øvrige
- Ballerup
- Fredag den 16. juli 2021
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|---|---|
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| 24. november 2024 | 55 |
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