Senior Regulatory Professional, Rare Diseases
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Søborg
Do you want to have a direct impact on developing life-changing and best-in class solutions for our patients? Would you like to be part of a late phase drug development project approaching marketing authorisation applications on a global scale? If you do, then join as a Senior Regulatory Affairs Professional within Rare Diseases. We are expanding the team and have an exciting role, where you get to have an opportunity to shape the direction of the department and make a significant impact from the beginning. Don't miss out on this incredible journey, apply now! The position In this role, you will get the opportunity to be part of a team working on a project in phase 3 within a rare disease area that soon will be facing a very exciting period of authority interactions and planning for marketing authorisation. Your key responsibilities will be to: Drive several regulatory tasks with challenging and often overlapping timelines Take part in cross-functional project and become a member of submission teams Interact with stakeholders across various departments, such as project management, medical and non-medical specialists, statisticians, and medical writers Development of regulatory documentation for submission to Health Authorities including response packages, clinical trial applications, paediatric investigation plans, labelling, and regulatory files for marketing authorisation Participate in department-related activities, including improvement projects across RA (Regulatory Affairs) You will report to the Associate Director of RA Rare Blood Disorders. Although we prefer that you work from our office in Søborg, Denmark, there is a possibility to work remotely for the right candidate. Qualifications
As an ideal candidate, you need to have: Master’s degree in Pharma, Natural Science or similar 4-5 years of regulatory or drug development experience Fluent written and spoken English language skills As a person, you thrive in a fast-paced working environment with unfamiliar situations. You bring a can-do attitude and demonstrate a flexible, change-oriented approach. It is also important to have a willingness to experiment and a tendency to view challenging situations as opportunities rather than limitations. Finally, you are a skilled communicator who can collaborate as a strategic business partner at any organizational level. 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 7 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 with colleagues from RA CMC (Chemistry, Manufacturing, and Controls), RA device, US etc., who all have important roles and contributions, and together form a team with the capacity to execute ambitions plans. 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 at +45 3448 0290. Deadline 01 June 2023. Relevant candidates will be invited for interview also before deadline. Should you wish to learn more about Regulatory Affairs careers, here may be a good place for you to begin: https://www.novonordisk.com/careers/career-areas/research-and-development/regulatory-affairs-careers.html You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. 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.
As an ideal candidate, you need to have:
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 7 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 with colleagues from RA CMC (Chemistry, Manufacturing, and Controls), RA device, US etc., who all have important roles and contributions, and together form a team with the capacity to execute ambitions plans. 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 at +45 3448 0290. Deadline 01 June 2023. Relevant candidates will be invited for interview also before deadline. Should you wish to learn more about Regulatory Affairs careers, here may be a good place for you to begin: https://www.novonordisk.com/careers/career-areas/research-and-development/regulatory-affairs-careers.html You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. 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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 4.5.2023, 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.
- Øvrige
- Søborg
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