Regulatory Professional for development projects within NASH
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Søborg
XXX Are you able to cut through complexity and drive regulatory processes for high impact projects and would you like to work together with experts across multiple functions in a global environment? Do you want to have the opportunity to continue your individual development in a dynamic, innovative, and collaborative environment?
If yes, apply now and join our team as a Regulatory Professional in 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 treatment to patients across the globe. The position
As RA Professional for development projects within NASH (Non-Alcoholic SteatoHepatitis), you will work closely with the global regulatory leads and Senior Professionals, and be responsible for driving and supporting several regulatory tasks with challenging and often overlapping timelines .
The projects are pursuing an indication within NASH (MASH according to new nomenclature) where there’s yet no approved medicinal product, with a high unmet medical need, and in a regulatory environment that is still in its infancy. A combination that makes the position truly exiting and with great room for innovation and drive.
You will report to the Manager of RA Liver and take active part in department-related activities, including improvement projects across RA.
Your main responsibilities will include: Implementation of regulatory strategy in clinical trial protocols and clinical trial applications Preparation of regulatory documentation for submission to Health Authorities and handling of response packages for Health Authorities Preparation of briefing packages for interactions with Health Authorities globally Participation in and preparation of labelling documents for submissions Interactions with stakeholders in affiliates to ensure alignment between local and global regulatory documentation and strategies
You will among others interact with project management, medical and non-clinical specialists, statisticians, and medical writers. You will be part of regulatory matrix team driven by a Global Regulatory Lead, where you will collaborate with regulatory colleagues from CMC (Chemistry, Manufacturing and Control), device and digital areas.
Our commitment to innovation also applies to the way we work. We therefore embrace the option of being at the office 3 days per week – with a blend of home office in Denmark and on-site office-based work in Søborg, Denmark where our team is based. Qualifications
As an ideal candidate, you should have: A master’s degree or Ph.D. related to Life Science or Health Science 3-4 years of regulatory or drug development experience in the pharmaceutical industry and with an understanding of the R&D value chain Experience in preparing and delivering regulatory documentation related to clinical drug development Professional proficiency in English
As a person, you are a team player who assists your colleagues and works for joint objectives, shows an inclusive mindset, and respects the diversity in others. You are flexible and change-oriented and like to experiment and see opportunities rather than limitations in challenging situations.
Finally, it is an advantage if you have a good sense of humor, and you can keep your spirits high even when under pressure. About the department
RA Obesity and Liver is a new and expanding area and will soon be 25 dedicated and highly engaged Managers, Global Regulatory leads, specialists, and regulatory professionals, organised into three teams. We are currently managing multiple active projects that span a wide array of domains and functional areas.
Our department is charged with delivering and executing global regulatory strategies. These strategies are designed to advance projects across multiple indications, from the early stages of development through to worldwide submission and approval of initial Marketing Authorisation applications.
We are responsible for driving regulatory strategy, label development, facilitating interactions with health authorities, and overseeing regulatory submissions. These submissions include initial marketing authorisation applications, paediatric plans, and clinical trial applications. We maintain strong ties with our affiliates and global stakeholders, fostering a close collaboration that is integral to our operations.
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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact David Truloff, Project Director RA Liver +45 30790499. Deadline
18 February 2024.XXX
If yes, apply now and join our team as a Regulatory Professional in 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 treatment to patients across the globe. The position
As RA Professional for development projects within NASH (Non-Alcoholic SteatoHepatitis), you will work closely with the global regulatory leads and Senior Professionals, and be responsible for driving and supporting several regulatory tasks with challenging and often overlapping timelines .
The projects are pursuing an indication within NASH (MASH according to new nomenclature) where there’s yet no approved medicinal product, with a high unmet medical need, and in a regulatory environment that is still in its infancy. A combination that makes the position truly exiting and with great room for innovation and drive.
You will report to the Manager of RA Liver and take active part in department-related activities, including improvement projects across RA.
Your main responsibilities will include:
You will among others interact with project management, medical and non-clinical specialists, statisticians, and medical writers. You will be part of regulatory matrix team driven by a Global Regulatory Lead, where you will collaborate with regulatory colleagues from CMC (Chemistry, Manufacturing and Control), device and digital areas.
Our commitment to innovation also applies to the way we work. We therefore embrace the option of being at the office 3 days per week – with a blend of home office in Denmark and on-site office-based work in Søborg, Denmark where our team is based. Qualifications
As an ideal candidate, you should have:
As a person, you are a team player who assists your colleagues and works for joint objectives, shows an inclusive mindset, and respects the diversity in others. You are flexible and change-oriented and like to experiment and see opportunities rather than limitations in challenging situations.
Finally, it is an advantage if you have a good sense of humor, and you can keep your spirits high even when under pressure. About the department
RA Obesity and Liver is a new and expanding area and will soon be 25 dedicated and highly engaged Managers, Global Regulatory leads, specialists, and regulatory professionals, organised into three teams. We are currently managing multiple active projects that span a wide array of domains and functional areas.
Our department is charged with delivering and executing global regulatory strategies. These strategies are designed to advance projects across multiple indications, from the early stages of development through to worldwide submission and approval of initial Marketing Authorisation applications.
We are responsible for driving regulatory strategy, label development, facilitating interactions with health authorities, and overseeing regulatory submissions. These submissions include initial marketing authorisation applications, paediatric plans, and clinical trial applications. We maintain strong ties with our affiliates and global stakeholders, fostering a close collaboration that is integral to our operations.
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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact David Truloff, Project Director RA Liver +45 30790499. Deadline
18 February 2024.XXX
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 31.1.2024, 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.
- Apoteker
- Søborg
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