Principal Regulatory Associate, opportunity within Regulatory Affairs, Rare Blood Disorders
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Søborg
Senior Regulatory Associate
Are you ready for a job at NovoNordisk? We need you in Regulatory Affairs (RA) where we are a group of engaged people who like to deliver and have fun. In RA we ensure approval of Novo Nordisk’s medicines by health authorities across the globe. We have a unique combination of scientific insight and the ability to navigate tight deadlines and many stakeholders.
What we need is you - who understand some science, thrive with tight deadlines, excel when it comes to systems and IT, and who put a pride in supporting and helping others.
The position
Being a Senior Regulatory Associate, you will be an active player in relation to planning, preparation, submission and approvals of high-quality clinical trial applications, marketing authorisation applications, variation applications, IND and NDA annual reports and many more regulatory documents. You will also be supporting the compilation of scientific documentation for regulatory authorities.
In this role it is important to understand and operate in Novo Nordisk IT systems. You must ensure regulatory compliance and tracking of key data in the relevant systems according to relevant procedures and IT systems.
You will daily collaborate with many stakeholders and affiliates around the world. You will work in a fast-paced environment with the focus of progression of key regulatory activities. You will be supported by a team of friendly colleagues who will be ready to help you.
Qualifications
You have a flair for IT systems and experience with MS Office applications as you will be responsible for managing data entry and electronic filing in our various databases and document management systems.
Your educational background enables you to work in administrative contexts and preferably you have experience from a heath care setting. You may have some years of experience from working in Regulatory Affairs.
You pay attention to details while maintaining the big picture. You are a structured proactive problem-solver, have a can-do attitude and a supportive mindset.
You have strong communication skills, and you easily build relations and maintain trustful partnerships with your colleagues and collaborators. You are comfortable speaking and writing in English. You can work independently, but you are also the team player who contributes to the good atmosphere in our department.
About the department
RA Rare Blood Disorders department is part of Global Regulatory Affairs and situated in Søborg, Denmark. We are contributing to the development of different products and projects within Rare Blood Disorders with a pipeline including a variety of different modalities and technologies.
We are a department with 21 dedicated and highly engaged employees of 10 different nationalities with diverse backgrounds and experiences. We work in groups where trust, openness, sparring, challenge and innovation fosters an inclusive and collaborative culture we all enjoy being part of.
Working at Novo Nordisk
At Novo Nordisk we strive for excellence. As a world leader in diabetes care, rare diseases and other serious chronic diseases, we are proud to make a difference for millions of people around the world. We know that results are made together, and that great opportunities for personal and professional growth are important to provide.
Contact
If you have questions about the position, you are welcome to contact Jane Møll Pedersen + 45 30753759
Deadline
15 January 2023, however relevant candidates may be invited for interview before deadline.
To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds, and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
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Are you ready for a job at NovoNordisk? We need you in Regulatory Affairs (RA) where we are a group of engaged people who like to deliver and have fun. In RA we ensure approval of Novo Nordisk’s medicines by health authorities across the globe. We have a unique combination of scientific insight and the ability to navigate tight deadlines and many stakeholders.
What we need is you - who understand some science, thrive with tight deadlines, excel when it comes to systems and IT, and who put a pride in supporting and helping others.
The position
Being a Senior Regulatory Associate, you will be an active player in relation to planning, preparation, submission and approvals of high-quality clinical trial applications, marketing authorisation applications, variation applications, IND and NDA annual reports and many more regulatory documents. You will also be supporting the compilation of scientific documentation for regulatory authorities.
In this role it is important to understand and operate in Novo Nordisk IT systems. You must ensure regulatory compliance and tracking of key data in the relevant systems according to relevant procedures and IT systems.
You will daily collaborate with many stakeholders and affiliates around the world. You will work in a fast-paced environment with the focus of progression of key regulatory activities. You will be supported by a team of friendly colleagues who will be ready to help you.
Qualifications
You have a flair for IT systems and experience with MS Office applications as you will be responsible for managing data entry and electronic filing in our various databases and document management systems.
Your educational background enables you to work in administrative contexts and preferably you have experience from a heath care setting. You may have some years of experience from working in Regulatory Affairs.
You pay attention to details while maintaining the big picture. You are a structured proactive problem-solver, have a can-do attitude and a supportive mindset.
You have strong communication skills, and you easily build relations and maintain trustful partnerships with your colleagues and collaborators. You are comfortable speaking and writing in English. You can work independently, but you are also the team player who contributes to the good atmosphere in our department.
About the department
RA Rare Blood Disorders department is part of Global Regulatory Affairs and situated in Søborg, Denmark. We are contributing to the development of different products and projects within Rare Blood Disorders with a pipeline including a variety of different modalities and technologies.
We are a department with 21 dedicated and highly engaged employees of 10 different nationalities with diverse backgrounds and experiences. We work in groups where trust, openness, sparring, challenge and innovation fosters an inclusive and collaborative culture we all enjoy being part of.
Working at Novo Nordisk
At Novo Nordisk we strive for excellence. As a world leader in diabetes care, rare diseases and other serious chronic diseases, we are proud to make a difference for millions of people around the world. We know that results are made together, and that great opportunities for personal and professional growth are important to provide.
Contact
If you have questions about the position, you are welcome to contact Jane Møll Pedersen + 45 30753759
Deadline
15 January 2023, however relevant candidates may be invited for interview before deadline.
To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds, and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Print job Send to e-mail
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 12.12.2022, 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
- Søborg
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