Senior Regulatory Expert
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Søborg
Do you want to have a life-changing impact? Are you a Regulatory Expert with a strong scientific and technical mindset and are excited to work with our diabetes and obesity portfolio?
If it sounds attractive to you, then this is your chance to join us in Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC), Diabetes & Obesity. Apply now!
The Position
We cover projects from the very earliest stages of the development towards the first marketing authorisation as well as continuing the product roll out globally and optimising the product throughout life cycle management.
In this position we guarantee that you will feel that your work has an impact by:
This role offers an opportunity for you to continue your individual development and connect your knowledge to the regulatory framework of CMC in benefit of the patients. You will work in a fast-paced environment with tight deadlines and work closely together with regulatory colleagues across our +80 offices around the world.
Qualifications
As an ideal candidate, you have:
On a personal level you:
About the department
RA CMC Diabetes & Obesity is part of Global Regulatory Affairs. We are committed to being one step ahead for our patients and for our business. The scope of our work spans across the entire research and development value chain, and therefore, we feel we are like the glue that connects research to commercial access. That goes from the earliest stages of drug development and research, and all the way to securing and maintaining commercial licenses for our life-changing treatments.
We are 45 colleagues working in different project teams from early phases of drug development throughout the life cycle of the marketed products worldwide. We are responsible for driving the RA CMC strategy and submission activities related to the drug of the drug-device development projects and the oral development projects.
Our work is essential to keep bringing innovative, patient-centric, and best-in-class solutions to our patients. That calls for team spirit, collaborative minds, skilled colleagues, and a great focus on knowledge-sharing. So, look forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture filled with humble people. The atmosphere is informal and good humour is always welcome. Our commitment to innovation also applies to the way we work: We embrace a flexible workplace, with a blend of in-office and remote work.
Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re in-spired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific re-search, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.
Contact
For further information please contact Samantha Donslund Schwab (+45 30794018) or Jeppe Engelheim Müggler (+45 30756025).
Deadline
22 January 2023. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline.
We are looking for several similar profiles at Novo Nordisk now. Therefore, Hiring Managers from different teams might also look at your application.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. 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.
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If it sounds attractive to you, then this is your chance to join us in Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC), Diabetes & Obesity. Apply now!
The Position
We cover projects from the very earliest stages of the development towards the first marketing authorisation as well as continuing the product roll out globally and optimising the product throughout life cycle management.
In this position we guarantee that you will feel that your work has an impact by:
- Being the voice of Regulatory Affairs CMC
- Providing scientific and strategic input to the projects and obtain the regulatory approvals
- Turning your scientific knowledge into regulatory pathways and develop global regulatory CMC strategies based on current legislation and regulations
- Being responsible for planning, coordinating and reviewing regulatory documentation related to the drug e.g. supporting preparation of applicable sections of submission packages, responses to agency questions for global markets and Agency Meeting Packages.
This role offers an opportunity for you to continue your individual development and connect your knowledge to the regulatory framework of CMC in benefit of the patients. You will work in a fast-paced environment with tight deadlines and work closely together with regulatory colleagues across our +80 offices around the world.
Qualifications
As an ideal candidate, you have:
- A Master’s degree or Ph.d. in science, pharmaceutical science, engineering, or another relevant academic field
- +5 years of experience working with Regulatory Affairs, preferably within CMC
- Fluent written and spoken English
On a personal level you:
- Are curious to learn, proactive and solution oriented
- Have a strategic mindset and the ability to set direction for your projects
- Challenge the discussions and contribute to project team decisions for the project you work with
- Have great communication skills and the ability to communicate scientifically difficult topics so it is easily understood by different kinds of stakeholders like R&D, Commercial and the Health Authorities.
- Bring a positive attitude and are self-motivated.
About the department
RA CMC Diabetes & Obesity is part of Global Regulatory Affairs. We are committed to being one step ahead for our patients and for our business. The scope of our work spans across the entire research and development value chain, and therefore, we feel we are like the glue that connects research to commercial access. That goes from the earliest stages of drug development and research, and all the way to securing and maintaining commercial licenses for our life-changing treatments.
We are 45 colleagues working in different project teams from early phases of drug development throughout the life cycle of the marketed products worldwide. We are responsible for driving the RA CMC strategy and submission activities related to the drug of the drug-device development projects and the oral development projects.
Our work is essential to keep bringing innovative, patient-centric, and best-in-class solutions to our patients. That calls for team spirit, collaborative minds, skilled colleagues, and a great focus on knowledge-sharing. So, look forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture filled with humble people. The atmosphere is informal and good humour is always welcome. Our commitment to innovation also applies to the way we work: We embrace a flexible workplace, with a blend of in-office and remote work.
Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re in-spired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific re-search, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.
Contact
For further information please contact Samantha Donslund Schwab (+45 30794018) or Jeppe Engelheim Müggler (+45 30756025).
Deadline
22 January 2023. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline.
We are looking for several similar profiles at Novo Nordisk now. Therefore, Hiring Managers from different teams might also look at your application.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. 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.
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 22.12.2022, 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
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