Regulatory Professional in Global Regulatory Affairs
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Søborg
Would you like to work on regulatory aspects in a global environment with international stakeholders? Does working with experts from many different professional backgrounds and cultures inspire you? Do you want to be part of a working environment where we are committed to gain approval of Novo Nordisk’s medicines to bring innovative treatment to patients across the globe? Then we offer you this exciting opportunity in Global Regulatory Affairs (GRA). Apply today and join us in Søborg for a life-changing career.
The position
As a Regulatory Professional, you will be responsible for driving and supporting several regulatory tasks with challenging and often overlapping timelines. You will be a member of cross-functional project and submission teams, and as such, interact with a variety of stakeholders from different functional areas in Novo Nordisk. You will participate in and be responsible for the development of regulatory documentation for submission to Health Authorities, including response packages for Health Authorities, clinical trial applications, clinical trial reports and regulatory files for marketing authorisation. Furthermore, you will be expected to be curious, proactive, and bold, challenge the discussions and contribute to project team decisions. You will among others interact with project management, medical and non-clinical specialists, statisticians, and medical writers.
This job offers ample opportunity for you to continue your individual development and stay updated within relevant regulatory and biotech disciplines. Your collaborative skills will be trained well and further developed, and you can expect to build an extensive internal network. You will report to the Senior Director of Regulatory Affairs for Rare Blood Disorders (RA RBD) and take active part in department related activities, including improvement projects across GRA.
Qualifications
To succeed in this role, we expect you to have:
You bring a can-do spirit and a healthy sense of humour to work. You are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging situations. As a person you thrive in a fast-paced work environment and sometimes in unfamiliar situations. It is important for you to feel that you are part of a team and an active contributor to the success of the team.
About the department
You will join the department of Regulatory Affairs for Rare Blood Disorders (RA RBD) within Global Regulatory Affairs situated in Søborg, Denmark. We work on development projects ranging from early research entailing candidate selection through to late-stage development and filing of Marketing Authorization applications globally. We have a broad and expanding portfolio within Rare Blood Disorders, indications that severely affects people globally in need of more efficient and safe treatment options.
We are currently 21 dedicated and highly engaged employees of 10 different nationalities with diverse backgrounds and experiences. We work in a flexible set-up where trust & openness, sparring, challenge and knowledge sharing fosters an inclusive and innovative culture we all enjoy being part of. The atmosphere is informal and good humour is always welcome. We work as an integrated part of the drug development cross-functional project team. We are responsible for the regulatory strategies and provide regulatory expertise and tactics to the product development plan. We drive product labelling, Health Authority interactions and clinical trial applications. We have a strong collaboration with our stakeholders in affiliates and work in global regulatory matrix teams with colleagues from RA CMC, RA device, US etc.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Jane Møll Pedersen +45 30753759.
Deadline
22 January 2023. Please note that we will conduct interviews on an ongoing basis, so please submit your application as soon as possible.
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.
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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The position
As a Regulatory Professional, you will be responsible for driving and supporting several regulatory tasks with challenging and often overlapping timelines. You will be a member of cross-functional project and submission teams, and as such, interact with a variety of stakeholders from different functional areas in Novo Nordisk. You will participate in and be responsible for the development of regulatory documentation for submission to Health Authorities, including response packages for Health Authorities, clinical trial applications, clinical trial reports and regulatory files for marketing authorisation. Furthermore, you will be expected to be curious, proactive, and bold, challenge the discussions and contribute to project team decisions. You will among others interact with project management, medical and non-clinical specialists, statisticians, and medical writers.
This job offers ample opportunity for you to continue your individual development and stay updated within relevant regulatory and biotech disciplines. Your collaborative skills will be trained well and further developed, and you can expect to build an extensive internal network. You will report to the Senior Director of Regulatory Affairs for Rare Blood Disorders (RA RBD) and take active part in department related activities, including improvement projects across GRA.
Qualifications
To succeed in this role, we expect you to have:
- A university degree in life or health science, and 3-4 years of regulatory or drug development experience. Alternatively, you hold a Ph.D. degree
- Strong written and verbal communication skills in English
- Experience with collaboration as a strategic business partner at any organisational level
You bring a can-do spirit and a healthy sense of humour to work. You are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging situations. As a person you thrive in a fast-paced work environment and sometimes in unfamiliar situations. It is important for you to feel that you are part of a team and an active contributor to the success of the team.
About the department
You will join the department of Regulatory Affairs for Rare Blood Disorders (RA RBD) within Global Regulatory Affairs situated in Søborg, Denmark. We work on development projects ranging from early research entailing candidate selection through to late-stage development and filing of Marketing Authorization applications globally. We have a broad and expanding portfolio within Rare Blood Disorders, indications that severely affects people globally in need of more efficient and safe treatment options.
We are currently 21 dedicated and highly engaged employees of 10 different nationalities with diverse backgrounds and experiences. We work in a flexible set-up where trust & openness, sparring, challenge and knowledge sharing fosters an inclusive and innovative culture we all enjoy being part of. The atmosphere is informal and good humour is always welcome. We work as an integrated part of the drug development cross-functional project team. We are responsible for the regulatory strategies and provide regulatory expertise and tactics to the product development plan. We drive product labelling, Health Authority interactions and clinical trial applications. We have a strong collaboration with our stakeholders in affiliates and work in global regulatory matrix teams with colleagues from RA CMC, RA device, US etc.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Jane Møll Pedersen +45 30753759.
Deadline
22 January 2023. Please note that we will conduct interviews on an ongoing basis, so please submit your application as soon as possible.
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.
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 5.1.2023, 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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