Regulatory Professional - RA Advanced Therapy Medicinal Products

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Søborg

  • Regulatory
  • Søborg

Join Regulatory Affairs in Novo Nordisk and become part of an exciting environment where engaged people work with new and exploratory technologies to bring innovative medicines to patients across the globe. Our people in Regulatory Affairs have a unique combination of scientific and regulatory insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.

About the department

The department of Advanced Therapy Medicinal Products is a newly established unit within Regulatory Affairs in Novo Nordisk. We work on early development projects with focus on new innovative technologies such as RNA interference, gene editing and DNA immunization within a wide range of diseases, including but not limited to hemophilia, T1DM, NASH, and sickle cell disease. We are currently four dedicated and highly engaged employees working in the department.

We work as an integrated part of global cross-functional project-teams with stakeholders ranging from research to market access. We are responsible for the regulatory strategy, and we provide regulatory expertise and tactics to the product development. We drive Health Authority interactions, clinical trial applications, new drug applications and label development.

We are looking for a Regulatory Professional with a strong scientific background who has a genuine interest in being part of the future of new technologies that can bring innovative medicines to patients worldwide.

The job

As a Regulatory Professional, you will be responsible for driving and supporting several regulatory tasks with challenging and often overlapping timelines.

You will be member of cross-functional project teams including study groups and submission teams, and as such, interact with a variety of stakeholders from different areas of Novo Nordisk. You will participate in and drive the development of regulatory documentation to Health Authorities, including briefing packages for meetings with Health Authorities, clinical trial applications and clinical trial protocols. You are expected to be curious about the competitive landscape, and to provide regulatory input to projects, be proactive and challenging, and contribute to project team decisions.

You will report to the Manager of RA Advanced Therapy Medicinal Products and take active part in department related activities, including improvement projects across RA.

Qualifications

We expect you to have a university degree within Natural- or Health sciences, preferably with a PhD with focus on innovative technologies as those mentioned above. Relevant working experience (e.g. regulatory sciences, clinical and non-clinical drug-development) is considered an advantage.

As a person you thrive in a busy work environment. You have a can-do attitude and bring a healthy sense of humor to work, even when the pressure is high. You are a flexible and change-oriented person who thinks out of the box and enjoys suggesting and implementing unconventional solutions. Finally, you have an excellent command of English, both oral and written.

Working at Novo Nordisk

At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.

Contact

For further information, please contact Tara Laura Brandt Elvang +45 3075 2456

Deadline

23rd February 2020, however applications will be read and reacted upon as they come in.

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.


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 31.1.2020, men kan have været deaktiveret og genaktiveret igen.

Rapportér
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Apoteker
  • Søborg
Rapportér

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