Senior Regulatory Professional, Cardio-vascular Diseases
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Søborg
Are you able to cut through complexity and drive regulatory strategies for high impact projects, where we strive to address highest unmet medical needs for our patients? Would you like to work together with experts across multiple functions in a global environment?
Then join Regulatory Affairs (RA) and become part of an exciting environment, where engaged people are committed to gain approval of Novo Nordisk’s medicines to bring innovative treatments to patients across the globe. We currently have openings for a Senior Regulatory Professional and a Regulatory Professional. Apply now!
The position
As a Senior Regulatory Professional or Regulatory Professional, you will be responsible for driving 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 departments in Novo Nordisk.
Your tasks will include the following:
You will report to the Senior Director of RA CVD-CKD (cardio-vascular and chronic kidney diseases) and take active part in department related activities, including improvement projects across RA.
Qualifications
As a person, you thrive in a fast-paced work environment with unfamiliar situations. You bring a can-do spirit and a healthy sense of humor to your work. You are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging 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. You are a skilled communicator who can collaborate as a strategic business partner at any organizational level.
About the department
RA CVD-CKD department is part of Global Regulatory Affairs and situated in Søborg, Denmark. We are contributing to the development of different products and projects within the cardio-vascular and chronic kidney diseases field working with a pipeline including early and late phase projects that investigates a variety of different modalities and technologies including monoclonal antibodies and oral administered peptides.
Our department is made up of 10 dedicated and highly engaged employees with diverse backgrounds and experience. We work as an integrated part of global development, research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies, provide regulatory expertise and tactics to the product development plan. We drive product labelling, Health Authority interactions and clinical trial applications.
Working at Novo Nordisk
At Novo Nordisk, we do not wait for change. We drive it. We are 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 are all working to move the needle on patient care.
Contact
For further information, please contact Anne Mette Holm +45 3079 5430 or Poul-Martin Haahr at +45 3075 4082.
Deadline
Deadline 20 November 2022. Relevant candidates will be invited for interview also before deadline.
Please include a few sentences about why you are applying for this position in your resume or CV. You do not need to attach a cover letter to your application. To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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.
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Then join Regulatory Affairs (RA) and become part of an exciting environment, where engaged people are committed to gain approval of Novo Nordisk’s medicines to bring innovative treatments to patients across the globe. We currently have openings for a Senior Regulatory Professional and a Regulatory Professional. Apply now!
The position
As a Senior Regulatory Professional or Regulatory Professional, you will be responsible for driving 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 departments in Novo Nordisk.
Your tasks will include the following:
- Development of regulatory documentation for submission to Health Authorities, including response packages for Health Authorities, clinical trial applications, clinical trial reports and regulatory file for marketing authorisation
- Contribute to the global regulatory strategies and tactics, be proactive and bold, challenge the discussions and contribute to project team decisions
- Interact with project management, medical and non-clinical specialists, statisticians, and medical writers
You will report to the Senior Director of RA CVD-CKD (cardio-vascular and chronic kidney diseases) and take active part in department related activities, including improvement projects across RA.
Qualifications
- Academic degree in life science or similar, may be supplemented with a PhD degree
- Regulatory or drug development experience preferably from pharma industry
- Strong IT/digital skills
- Fluent written and spoken English
As a person, you thrive in a fast-paced work environment with unfamiliar situations. You bring a can-do spirit and a healthy sense of humor to your work. You are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging 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. You are a skilled communicator who can collaborate as a strategic business partner at any organizational level.
About the department
RA CVD-CKD department is part of Global Regulatory Affairs and situated in Søborg, Denmark. We are contributing to the development of different products and projects within the cardio-vascular and chronic kidney diseases field working with a pipeline including early and late phase projects that investigates a variety of different modalities and technologies including monoclonal antibodies and oral administered peptides.
Our department is made up of 10 dedicated and highly engaged employees with diverse backgrounds and experience. We work as an integrated part of global development, research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies, provide regulatory expertise and tactics to the product development plan. We drive product labelling, Health Authority interactions and clinical trial applications.
Working at Novo Nordisk
At Novo Nordisk, we do not wait for change. We drive it. We are 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 are all working to move the needle on patient care.
Contact
For further information, please contact Anne Mette Holm +45 3079 5430 or Poul-Martin Haahr at +45 3075 4082.
Deadline
Deadline 20 November 2022. Relevant candidates will be invited for interview also before deadline.
Please include a few sentences about why you are applying for this position in your resume or CV. You do not need to attach a cover letter to your application. To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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.
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 2.11.2022, 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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