Regulatory Affairs Expert for Rare Diseases area
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Søborg
Are you able to take the lead and drive regulatory activities with high impact? Do you want to have a key role in the strategy for filing for a new treatment for rare diseases? W e are looking for an experienced Regulatory Specialist to join the Global Regulatory Affairs team at Novo Nordisk where individuals work to gain approval for the company's innovative medicines worldwide. If you are ready to take on a strategic position and contribute to the global regulatory strategy, read on and apply today for a life-changing career!
The position
As a Regulatory Specialist in our department, you will have the opportunity to demonstrate leadership of complex regulatory activities in development projects and in highly scientific settings. It is a strategic position and requires leadership, regulatory experience, and drug development proficiency. This project is entering an exciting phase of engaging with regulatory authorities and strategizing for Marketing Authorization Applications and roll-out. In this position specifically, you will be the lead in strategic regulatory activities, including: Leading the filing strategy for a phase 3 asset and taking the lead on major submission tracks such as submission country lead, where you will be working with stakeholders in affiliates to ensure alignment between local and global regulatory strategies and timely preparation of regulatory documentation Contributing to the global regulatory strategy by providing innovative regulatory expertise and tactics throughout the development stage Taking the lead on strategic regulatory activities and deliverables such as claims development Leading and coordinating preparation of meeting packages to Health Authorities and facilitating and conducting Health Authority interactions Leading discussions around innovative endpoints – including PROs with Health Authorities In addition to contributing to a late-stage project, you will also can work with early clinical development as Global Regulatory lead for an early project. You will join a project in its advanced development stage, focusing on a rare disease. The area is a new focus area for Novo Nordisk with an exciting pipeline, and there will be plenty of opportunity for the right candidate for stretched assignments and development opportunities. 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 work in Søborg, Denmark where our team is based. Qualifications
To succeed in this role, you need the following: A master’s degree or a Ph.D. within Life or Health Science Several years of regulatory experience in the pharmaceutical industry with a thorough understanding of the R&D value chain Solid experience in preparing and delivering global regulatory strategies across the major regulatory agencies globally and handling of regulatory documentation for pharmaceutical development (quality, non-clinical and clinical) Pharmaceutical industry knowledge and experience in interacting directly with regulatory authorities on an international scale Strong negotiation skills and a sound business understanding Experience with validation of PROs is an advantage
As an individual, you are creative, proactive, independent, and possess a drive for success. You are solutions-oriented and can keep your spirits high even when under pressure. Furthermore, you thrive in challenging and ambiguous situations, approaching them with a flexible and experimental mindset. Adaptability and a willingness to embrace change are essential.
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 12 dedicated and highly engaged employees with diverse backgrounds and experiences. We value trust and 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 a strong collaboration with our stakeholders in affiliates and work in global regulatory matrix teams.
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, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Marie Aavang Geist, Director at +45 3448 0290.
Deadline
10 March 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.
The position
As a Regulatory Specialist in our department, you will have the opportunity to demonstrate leadership of complex regulatory activities in development projects and in highly scientific settings. It is a strategic position and requires leadership, regulatory experience, and drug development proficiency. This project is entering an exciting phase of engaging with regulatory authorities and strategizing for Marketing Authorization Applications and roll-out. In this position specifically, you will be the lead in strategic regulatory activities, including:
To succeed in this role, you need the following:
As an individual, you are creative, proactive, independent, and possess a drive for success. You are solutions-oriented and can keep your spirits high even when under pressure. Furthermore, you thrive in challenging and ambiguous situations, approaching them with a flexible and experimental mindset. Adaptability and a willingness to embrace change are essential.
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 12 dedicated and highly engaged employees with diverse backgrounds and experiences. We value trust and 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 a strong collaboration with our stakeholders in affiliates and work in global regulatory matrix teams.
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, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Marie Aavang Geist, Director at +45 3448 0290.
Deadline
10 March 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 17.1.2024, 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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