Senior Regulatory Professional - Rare Disease
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Søborg
Are you able to cut through complexity and drive regulatory strategies for high impact projects, where we strive to address the unmet medical needs for our patients? Would you like to work together with experts across multiple functions in a global environment?
Then join Global Regulatory Affairs in Novo Nordisk and become part of an exciting environment where engaged people are committed to gain approval of Novo Nordisk’s medicines to bring innovative treatment to patients across the globe. We have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes RA a truly interesting and dynamic place to work. Apply now for a life-changing career!
The position
As Senior Regulatory Professional or Regulatory Professional in our area, you will be part of a fantastic team of 8 people. You will be responsible for driving several clinical regulatory activities within rare disease drug development projects. 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.
Your tasks will include:
You will report to the Director of RA Rare Endocrine Disorders and take active part in department related activities, including improvement projects across Global RA.
You will work in a fast-paced environment with tight deadlines where no two days are alike, and you will be supported by friendly colleagues.
Your qualifications
About the department
You will join the department of RA Rare Endocrine Disorders within Global Regulatory Affairs situated in Søborg, Denmark. We are currently 8 dedicated and highly engaged employees in the department with diverse background and experience. 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. The atmosphere is informal and good humour is always welcome
We work as an integrated part of the drug development project teams and we have a strong collaboration with our stakeholders in affiliates and work in global regulatory matrix teams with colleagues from RA CMC, RA device, RA labelling etc. We are responsible for setting the regulatory strategic direction for the rare endocrine portfolio, and we drive all regulatory activities on projects ranging from early research through to late-stage development and filing of marketing authorisation applications globally. We drive product labelling, Health Authority interactions, clinical trial applications and marketing authorisation applications world-wide.
Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing.
Contact
For further information, please contact Eva Lisby Arp-Hansen +45 3079 0241
Deadline
Please apply for the position no later than 05 December 2022.
Interviews will be conducted continuously. Please submit your application online at your earliest convenience, including a motivational letter and CV in English. 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.
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Then join Global Regulatory Affairs in Novo Nordisk and become part of an exciting environment where engaged people are committed to gain approval of Novo Nordisk’s medicines to bring innovative treatment to patients across the globe. We have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes RA a truly interesting and dynamic place to work. Apply now for a life-changing career!
The position
As Senior Regulatory Professional or Regulatory Professional in our area, you will be part of a fantastic team of 8 people. You will be responsible for driving several clinical regulatory activities within rare disease drug development projects. 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.
Your tasks will include:
- Participate in the development and submission of regulatory documentation to Health Authorities e.g. response packages, briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports and regulatory files for marketing authorisation
- Provide input to the global regulatory strategies and tactics, be proactive and bold, challenge the discussions and contribute to project team decisions
- Act as member of cross-functional project teams including study groups and submission teams
- Interact with project management, medical and non-clinical specialists, statisticians, and medical writers
You will report to the Director of RA Rare Endocrine Disorders and take active part in department related activities, including improvement projects across Global RA.
You will work in a fast-paced environment with tight deadlines where no two days are alike, and you will be supported by friendly colleagues.
Your qualifications
- Your background covers a master’s degree within life sciences with 3-6 years of regulatory affairs experience or other relevant drug development experience from the pharmaceutical industry.
- You have an all-round understanding of regulatory requirements for drug development. You are driven by science and innovation, can understand complex scientific issues, and will be able to bring them into a regulatory context.
- You are well organized and have solid problem-solving capabilities. As a person you thrive in a busy environment; bring a can-do spirit and a healthy sense of humour to your work.
- You build effective working relations in global teams and are a flexible and change-oriented person who focuses on opportunities rather than limitations in challenging situations.
- The ideal candidate has ability to navigate in multiple tasks simultaneously with various stakeholders and in various systems.
- Finally, you possess excellent communication skills and are comfortable and competent to communicate in both verbal and written English
About the department
You will join the department of RA Rare Endocrine Disorders within Global Regulatory Affairs situated in Søborg, Denmark. We are currently 8 dedicated and highly engaged employees in the department with diverse background and experience. 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. The atmosphere is informal and good humour is always welcome
We work as an integrated part of the drug development project teams and we have a strong collaboration with our stakeholders in affiliates and work in global regulatory matrix teams with colleagues from RA CMC, RA device, RA labelling etc. We are responsible for setting the regulatory strategic direction for the rare endocrine portfolio, and we drive all regulatory activities on projects ranging from early research through to late-stage development and filing of marketing authorisation applications globally. We drive product labelling, Health Authority interactions, clinical trial applications and marketing authorisation applications world-wide.
Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing.
Contact
For further information, please contact Eva Lisby Arp-Hansen +45 3079 0241
Deadline
Please apply for the position no later than 05 December 2022.
Interviews will be conducted continuously. Please submit your application online at your earliest convenience, including a motivational letter and CV in English. 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.
Print job Send to e-mail
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 22.11.2022, 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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