Senior Regulatory Professional, Diabetes & Obesity
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Søborg
Do you want to play a key role in accelerating the development of our patient-focused products? Are you passionate about regulatory science and have experience in regulatory activities for the clinical development of innovative therapeutic medicines and devices to the benefit of patients?
If so, we at Novo Nordisk, invite you to become a part of our dynamic and forward-looking regulatory organisation. We are expanding our team of highly engaged professionals who play pivotal roles in developing medical solutions and obtaining marketing authorisations from regulatory authorities worldwide. We encourage you to apply now and join us in this exciting journey!
The position
We have two positions within Regulatory Affairs (RA) Diabetes and Obesity in which you will support the development of regulatory strategies and executing various regulatory tasks within cross-functional project teams. One Senior Regulatory Professional for a device project, where you will collaborate closely with the Global Regulatory Lead and the RA matrix team of experts within Regulatory specialities as well as external collaborators. You will collaborate with external organisations on regulatory documentation. One Senior Regulatory Professional for a project in clinical development, where you will collaborate closely with the Global Regulatory Lead and a team of regulatory professionals, working together to advance Phase II projects within multiple therapy areas. You may be an integral member of cross-functional project teams, including study groups, and submission teams. Please, note in your CV/Cover Letter if you have a specific preference.
Your main responsibilities will be focused on:
• Contributing with regulatory expertise to global strategies and tactics
• Participating in the development of regulatory documentation, such as briefing packages for Health Authority meetings, clinical trial applications, protocols and reports, paediatric development plans, and labelling
• Ensuring the timely submission of clinical trial applications to advance the clinical programme
• Working with regulatory colleagues, project management, medical and non-medical specialists, statisticians, and medical writers, providing regulatory input and contributing to project decisions
• Being involved in establishing internal positions on regulatory issues, new and changing guidelines, and improvement projects across Regulatory Affairs 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:
• Master's degree within Life Science, Health Science, or a related field
• 4-5 years of experience in Regulatory Affairs
• Track record or keen interest in therapeutic areas would be an advantage
• Strong IT/digital skills
• Professional proficiency in English
As a person, 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 David Truloff 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. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. Please assist us in maintaining a fair and inclusive selection process by not attaching a photo to your application.
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 so, we at Novo Nordisk, invite you to become a part of our dynamic and forward-looking regulatory organisation. We are expanding our team of highly engaged professionals who play pivotal roles in developing medical solutions and obtaining marketing authorisations from regulatory authorities worldwide. We encourage you to apply now and join us in this exciting journey!
The position
We have two positions within Regulatory Affairs (RA) Diabetes and Obesity in which you will support the development of regulatory strategies and executing various regulatory tasks within cross-functional project teams.
Your main responsibilities will be focused on:
• Contributing with regulatory expertise to global strategies and tactics
• Participating in the development of regulatory documentation, such as briefing packages for Health Authority meetings, clinical trial applications, protocols and reports, paediatric development plans, and labelling
• Ensuring the timely submission of clinical trial applications to advance the clinical programme
• Working with regulatory colleagues, project management, medical and non-medical specialists, statisticians, and medical writers, providing regulatory input and contributing to project decisions
• Being involved in establishing internal positions on regulatory issues, new and changing guidelines, and improvement projects across Regulatory Affairs 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:
• Master's degree within Life Science, Health Science, or a related field
• 4-5 years of experience in Regulatory Affairs
• Track record or keen interest in therapeutic areas would be an advantage
• Strong IT/digital skills
• Professional proficiency in English
As a person, 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 David Truloff 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. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. Please assist us in maintaining a fair and inclusive selection process by not attaching a photo to your application.
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 20.12.2023, 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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