Senior Regulatory Professional, Rare Diseases
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Søborg
Would you like to have the opportunity to work in an innovative and strategic Regulatory Affairs (RA) area? Do you want to be part of a new team that is growing?
Join us and become part of an exciting environment where engaged people are committed to gaining approval of Novo Nordisk’s medicines for rare blood disorders from regulatory authorities across the globe! The position
As a Senior Regulatory Professional, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. You will be a member of cross functional project and submission teams.
Your main responsibilities will include:
• Manage the development of regulatory documentation for submission to Health Authorities including response packages, clinical trial applications, pediatric investigation plans, labelling, and regulatory files for marketing authorisation
• Be part of several teams, partly supporting initiation of clinical trials for early projects and partly supporting a project in phase 3, both in rare diseases
• Take active part in department-related activities including improvement projects across RA
• Interact with a variety of stakeholders from different departments in Novo Nordisk such as project management, medical and non-clinical specialists, statisticians, and medical writers Qualifications
To be a competitive candidate you should have:
• A MSc degree related to Life Science. A PhD would be an advantage
• At least, 4-5 years of experience within regulatory or related disciplines
• Experience with major health authorities such as FDA or EMA
• Understanding of clinical or drug development
• Good communication skills to collaborate as a strategic business partner at any organizational level
As a person you thrive in a fast-paced working environment with unfamiliar situations. You bring a can-do spirit and are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging situations. About the department
In RA Rare Blood Disorders we contribute to the development of treatments within rare diseases like Sickle Cell Disease and Thalassemia where there is a high unmet need for treatment on a global scale. The pipeline includes a variety of different modalities and technologies.
We are a team of 11 dedicated and highly engaged employees with diverse backgrounds and experiences. We value trust & openness and work in an environment where sharing of knowledge, new ideas, and innovative approaches to regulatory strategy and tactics are highly appreciated.
We are an integrated part of the global development, research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and tactics and provide regulatory expertise to the product development plan. We drive product labelling, Health Authority interactions and clinical trial applications. We have strong collaboration with our stakeholders in affiliates and work in global regulatory matrix teams with colleagues from RA CMC, RA device, US etc. and together form a team with the capacity to execute ambitions plans. Working at Novo Nordisk
At Novo Nordisk, we do not 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, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Associate Director, Marie Aavang Geist +45 3448 0290. Deadline 3 December 2023. We will review the applications on an ongoing basis. 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.
Join us and become part of an exciting environment where engaged people are committed to gaining approval of Novo Nordisk’s medicines for rare blood disorders from regulatory authorities across the globe! The position
As a Senior Regulatory Professional, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. You will be a member of cross functional project and submission teams.
Your main responsibilities will include:
• Manage the development of regulatory documentation for submission to Health Authorities including response packages, clinical trial applications, pediatric investigation plans, labelling, and regulatory files for marketing authorisation
• Be part of several teams, partly supporting initiation of clinical trials for early projects and partly supporting a project in phase 3, both in rare diseases
• Take active part in department-related activities including improvement projects across RA
• Interact with a variety of stakeholders from different departments in Novo Nordisk such as project management, medical and non-clinical specialists, statisticians, and medical writers Qualifications
To be a competitive candidate you should have:
• A MSc degree related to Life Science. A PhD would be an advantage
• At least, 4-5 years of experience within regulatory or related disciplines
• Experience with major health authorities such as FDA or EMA
• Understanding of clinical or drug development
• Good communication skills to collaborate as a strategic business partner at any organizational level
As a person you thrive in a fast-paced working environment with unfamiliar situations. You bring a can-do spirit and are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging situations. About the department
In RA Rare Blood Disorders we contribute to the development of treatments within rare diseases like Sickle Cell Disease and Thalassemia where there is a high unmet need for treatment on a global scale. The pipeline includes a variety of different modalities and technologies.
We are a team of 11 dedicated and highly engaged employees with diverse backgrounds and experiences. We value trust & openness and work in an environment where sharing of knowledge, new ideas, and innovative approaches to regulatory strategy and tactics are highly appreciated.
We are an integrated part of the global development, research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and tactics and provide regulatory expertise to the product development plan. We drive product labelling, Health Authority interactions and clinical trial applications. We have strong collaboration with our stakeholders in affiliates and work in global regulatory matrix teams with colleagues from RA CMC, RA device, US etc. and together form a team with the capacity to execute ambitions plans. Working at Novo Nordisk
At Novo Nordisk, we do not 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, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Associate Director, Marie Aavang Geist +45 3448 0290. Deadline 3 December 2023. We will review the applications on an ongoing basis. 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 17.11.2023, 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
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