Regulatory and Senior Regulatory Professional (Maternity cover)
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Søborg
Are you passionate about regulatory science and executing on regulatory strategies to bring innovative medicines to patients? Do you want to have the opportunity to contribute and develop your skills in our dynamic regulatory organization? If yes, apply now and join us! We are looking for highly engaged professionals who play pivotal roles in developing medical solutions and obtaining Marketing Authorisations from regulatory authorities worldwide. The position
We have two vacant 12-month maternity leave positions within Regulatory Affairs (RA) Diabetes & Obesity Development Projects:
• one Senior Regulatory Professional position on a project in phase 2
• one Regulatory Professional position on a project in submission phase Please note in your CV/Cover Letter if you have a specific preference.
You will support the development of regulatory strategies and executing various regulatory tasks within cross-functional project teams. This will involve interacting with a diverse array of stakeholders throughout the process.
Depending on the project, the key responsibilities could include:
• Contribute regulatory expertise to global strategies and tactics
• Participate in the development of regulatory documentation, such as packages for Health Authority meetings, marketing authorization applications, clinical trial applications, protocols and reports, pediatric development plans, and labelling
• Ensure timely submission of clinical trial applications
• Work with regulatory colleagues, project management, medical and non-medical specialists, statisticians, and medical writers, providing regulatory input and contributing to project decisions Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and on-site office based work in Søborg, Denmark where our team is based.
Qualifications
To be a competitive candidate, you should have:
• A Master's degree within Life Science, Health Science, or a related field
• Experience in Regulatory Affairs or other relevant area in drug development
• Track record or keen interest in diabetes and obesity therapeutic areas would be an advantage
• Strong IT/digital skills
• Fluency in written and spoken English Personally, you thrive in team environments and actively contribute to their team's success. You should be well-organised, possess robust problem-solving capabilities, and maintain a strategic focus. A positive, can-do attitude is crucial, as is the ability to keep your spirits high and maintain a healthy sense of humour under pressure. Effective communication skills that enable cooperation at all organisational levels are highly valued.
About the department
RA Diabetes and Obesity Development Projects is expanding and will soon be 30 dedicated and highly engaged 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 on 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 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 Jenny Kastberg at [email protected].
Deadline
7 January 2024 Please note we will invite candidates for interviews on an ongoing basis and conclude the recruitment process when the right candidate has been found. 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.
We have two vacant 12-month maternity leave positions within Regulatory Affairs (RA) Diabetes & Obesity Development Projects:
• one Senior Regulatory Professional position on a project in phase 2
• one Regulatory Professional position on a project in submission phase Please note in your CV/Cover Letter if you have a specific preference.
You will support the development of regulatory strategies and executing various regulatory tasks within cross-functional project teams. This will involve interacting with a diverse array of stakeholders throughout the process.
Depending on the project, the key responsibilities could include:
• Contribute regulatory expertise to global strategies and tactics
• Participate in the development of regulatory documentation, such as packages for Health Authority meetings, marketing authorization applications, clinical trial applications, protocols and reports, pediatric development plans, and labelling
• Ensure timely submission of clinical trial applications
• Work with regulatory colleagues, project management, medical and non-medical specialists, statisticians, and medical writers, providing regulatory input and contributing to project decisions Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and on-site office based work in Søborg, Denmark where our team is based.
Qualifications
To be a competitive candidate, you should have:
• A Master's degree within Life Science, Health Science, or a related field
• Experience in Regulatory Affairs or other relevant area in drug development
• Track record or keen interest in diabetes and obesity therapeutic areas would be an advantage
• Strong IT/digital skills
• Fluency in written and spoken English Personally, you thrive in team environments and actively contribute to their team's success. You should be well-organised, possess robust problem-solving capabilities, and maintain a strategic focus. A positive, can-do attitude is crucial, as is the ability to keep your spirits high and maintain a healthy sense of humour under pressure. Effective communication skills that enable cooperation at all organisational levels are highly valued.
About the department
RA Diabetes and Obesity Development Projects is expanding and will soon be 30 dedicated and highly engaged 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 on 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 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 Jenny Kastberg at [email protected].
Deadline
7 January 2024 Please note we will invite candidates for interviews on an ongoing basis and conclude the recruitment process when the right candidate has been found. 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 15.12.2023, 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.
- Apoteker
- Søborg
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