Senior RA Professional for development projects within NASH
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Søborg
Are you able to cut through complexity and drive regulatory strategies 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 Senior 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 Senior RA Professional for development projects within NASH (Non-Alcoholic SteatoHepatitis), you will work closely with the global regulatory lead and take part in developing regulatory strategies and lead execution via interactions with cross-functional teams. The position will be on a Phase2 NASH project.
The project is 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: Contribute to global regulatory strategies and tactics providing your specialist knowledge via analysing regulatory opportunities and risks Ensure that the project strategy is implemented in clinical trial protocols and clinical trial applications Preparation of briefing packages for interactions with Health Authorities globally Development of global label claims and translating the claims to local label text for submissions in target countries Development of local strategies, where you will be working with stakeholders in affiliates to ensure alignment between local and global regulatory 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 Engineering At least, 5 years of regulatory experience in the pharmaceutical industry and with a good understanding of the R&D value chain Experience in preparing and delivering on global regulatory strategies, including employment of expedited and accelerated pathways across the major regulatory agencies globally and handling regulatory documentation for pharmaceutical development (quality, non-clinical and clinical) Professional proficiency in English Proactivity and experience setting clear direction and excellent project management skills
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 Marianne Bork Samuelsen, Project Director RA Liver +45 3079 6941. Deadline
18 February 2024. 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.
If yes, apply now and join our team as a Senior 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 Senior RA Professional for development projects within NASH (Non-Alcoholic SteatoHepatitis), you will work closely with the global regulatory lead and take part in developing regulatory strategies and lead execution via interactions with cross-functional teams. The position will be on a Phase2 NASH project.
The project is 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 Marianne Bork Samuelsen, Project Director RA Liver +45 3079 6941. Deadline
18 February 2024. 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.
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 29.1.2024, 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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