Senior Regulatory Professional within rare disease drug development
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Søborg
Research & Development Denmark - Søborg Join Regulatory Affairs (RA) and become part of an exciting environment where engaged people are committed to gain approval of Novo Nordisk’s medicines by regulatory authorities across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and ambitious place to work. This position offers a lifetime experience in terms of drug development - a culmination of many years of research and development, the current focus is the creation of a regulatory file with the purpose of obtaining marketing authorisation on a global scale. The job As a Senior Regulatory Professional, you will be responsible for driving several regulatory tasks with ambitious and often overlapping timelines. You will be a member of cross functional project and submission teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk. You will be part of the team clinical trial team responsible for clinical trial applications, amendments, and clinical trial reports. You will be responsible for the development of regulatory documentation for submission to health authorities, including information packages for authority meetings, response packages for health authorities, and regulatory file for marketing authorisation. Furthermore, you will be expected to contribute to the global regulatory strategies and tactics, be proactive and bold, challenge the discussions and contribute to project team decisions. You will among others interact with project management, medical and non-clinical specialists, statisticians, and medical writers. Specifically, for this job you will get the opportunity to be part of a team who right now are in phase 3 with a rare disease and soon will be facing a very exciting period of authority interactions and planning for obtaining the regulatory approval. You will report to the Senior Director of RA Rare Bleeding Disorders and take active part in department related activities, including improvement projects across RA. Qualifications
We expect you to have an university degree in life science and have 4-5 years of regulatory or drug development experience. As a person you thrive in a fast-paced work environment with unfamiliar situations. You bring a can-do spirit and a healthy sense of humor to your work. You are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging situations. It is important for you to feel that you are part of a team and an active contributor to the success of the team. You are a skilled communicator who can collaborate as a strategic business partner at any organizational level. Finally, you are comfortable using your fluent written and spoken English. About the department RA Rare Bleeding Disorders department is part of Global Regulatory Affairs and situated in Søborg, Denmark. We are contributing to the development of different products and projects within Rare Bleeding Disorders with a pipeline including a variety of different modalities and technologies including gene therapy. We are a department with 15 dedicated and highly engaged employees of 8 different nationalities with diverse backgrounds and experiences. We work in a flexible set-up where trust and openness, sparring, challenge, and knowledge sharing fosters an inclusive and innovative culture we all enjoy being part of. We work as an integrated part of the global development, research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and provide regulatory expertise and tactics 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, RA device, US etc., who all have important roles and contributions, and together form a team with the capacity to execute ambitious plans. Working at Novo Nordisk At Novo Nordisk, we use our skills, dedication, and ambition to help people with chronic diseases such as Rare Endocrine Disorders, Rare Blood Disorders, Diabetes, Obesity, NASH, and CVD/CKD. We offer the chance to be part of a truly global and highly diverse workplace, where passion and engagement are met with opportunities for professional and personal development. Contact For further information, please contact Senior Director Jane Møll Pedersen at +45 3075 3759. Deadline 12 November 2022. Relevant candidates will be invited for interview also before deadline. 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 do not add 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.
We expect you to have an university degree in life science and have 4-5 years of regulatory or drug development experience. As a person you thrive in a fast-paced work environment with unfamiliar situations. You bring a can-do spirit and a healthy sense of humor to your work. You are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging situations. It is important for you to feel that you are part of a team and an active contributor to the success of the team. You are a skilled communicator who can collaborate as a strategic business partner at any organizational level. Finally, you are comfortable using your fluent written and spoken English. About the department RA Rare Bleeding Disorders department is part of Global Regulatory Affairs and situated in Søborg, Denmark. We are contributing to the development of different products and projects within Rare Bleeding Disorders with a pipeline including a variety of different modalities and technologies including gene therapy. We are a department with 15 dedicated and highly engaged employees of 8 different nationalities with diverse backgrounds and experiences. We work in a flexible set-up where trust and openness, sparring, challenge, and knowledge sharing fosters an inclusive and innovative culture we all enjoy being part of. We work as an integrated part of the global development, research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and provide regulatory expertise and tactics 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, RA device, US etc., who all have important roles and contributions, and together form a team with the capacity to execute ambitious plans. Working at Novo Nordisk At Novo Nordisk, we use our skills, dedication, and ambition to help people with chronic diseases such as Rare Endocrine Disorders, Rare Blood Disorders, Diabetes, Obesity, NASH, and CVD/CKD. We offer the chance to be part of a truly global and highly diverse workplace, where passion and engagement are met with opportunities for professional and personal development. Contact For further information, please contact Senior Director Jane Møll Pedersen at +45 3075 3759. Deadline 12 November 2022. Relevant candidates will be invited for interview also before deadline. 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 do not add 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 "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 19.10.2023, 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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