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Regulatory Professional - RA Oral Peptide & CVD Projects

Novo Nordisk A/S

Gladsaxe, Storkøbenhavn

Indrykket
21-10-2020
Kontakt
Novo Nordisk A/S
Vandtårnsvej 108
2860
Søborg
Tlf
30757225
Praktisk information
Oprettet
21-10-2020
Udløber
01-11-2020
Kviknummer
330394876
Jobtype
Fuldtid
Arbejdsområde
Jura
Stillingsbetegnelse
Advokat
Erfaringer - I højere grad
Ikke angivet (Jura og retsvæsen)
Sprog
Dansk Læse/ tale

Join Regulatory Affairs (RA) and become part of an exciting environment where engaged people are committed gaining 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 challenging place to work.

 

About the department
RA Oral Peptide & Cardiovascular Disease (CVD) Projects is part of Global Regulatory Affairs and situated in Søborg, Denmark. We are responsible for development projects within the innovative new delivery technology that brings peptides in tablets available to patients and development projects for cardiovascular diseases. We are a team with dedicated and highly engaged employees with diverse background and experience. We have a high sense of commitment, respect and strive for a workday with interesting tasks, learnings and a good and open atmosphere.

 

We work as an integrated part of the global development and research project teams and cross-functional sub-teams. We are responsible for the regulatory strategy and provide regulatory expertise and tactics to the product development plan. We drive label development, Health Authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and work in global regulatory teams.

We are currently looking for a new colleague 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 required to drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines.

You will be a member of cross functional project teams including study groups and submission teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk. You will participate in the development of regulatory documentation for submission to Health Authorities, including briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports and regulatory files for marketing authorization. Furthermore, you will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions. You will among others interact with medical and non-clinical specialists, statisticians and medical writers.

 

You will report to the Senior Director of RA Oral Peptide & CVD Projects and take active part in department related activities, including improvement projects across RA.

 

Qualifications
We expect you to have a university degree in life science and have a few years of regulatory and drug development experience.

As a person you thrive in a busy environment; bring can-do spirit and a healthy sense of humor to your work – even when the pressure is on. You are a flexible and change-oriented person who focuses on opportunities rather than limitations in challenging situations. You are a skilled communicator who can cooperate at any organizational level. Finally, you are comfortable using your fluent written and spoken English on a daily basis.

 

Working at Novo Nordisk
At Novo Nordisk, we use our skills, dedication and ambition to help people with chronic diseases such as Diabetes, Obesity, NASH, CVD, Rare Endocrine Disorders as well as Rare Blood Disorders. 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 Vibeke Hatorp at +45 3075 5697.

 

Deadline
1 November 2020

 

 

 

 

 

 

 

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 chronic 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.
 

Ansøg nu
Lignende job
Virksomhedsinformation
Novo Nordisk A/S
Vandtårnsvej 108
2860
Søborg
Tlf
30757225
Praktisk information
Oprettet
21-10-2020
Udløber
01-11-2020
Kviknummer
330394876
Jobtype
Fuldtid
Arbejdsområde
Jura
Stillingsbetegnelse
Advokat
Erfaringer - I højere grad
Ikke angivet (Jura og retsvæsen)
Sprog
Dansk Læse/ tale
Beliggenhed