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documentId: 5004660

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stillingsbetegnelse: Senior Regulatory Professional in RA CMC Biopharm

jobbeskrivelse:

The employees in Regulatory Affairs (RA) have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders simultaneously. Join a fast-changing environment where engaged people do their best every day to obtain and maintain clinical trial applications and market authorisations worldwide for all Novo Nordisk medicinal products across the globe. This makes RA a truly interesting place to work – but also quite challenging. Are you up for this challenge in the near future?

About the department
The department “RA Biopharm 2” is part of RABiopharm in Regulatory Affairs and is situated in the Novo Nordisk project house together with other regulatory affairs functions in Søborg. We are a group of highly skilled and dedicated people involved in every clinical and non-clinical aspects concerning marketed products as well as projects in development within Haemophilia and Growth Hormone disorders. The project portfolio is developing and in order to be able to handle the tasks and challenges within our area of responsibility we are looking for one more colleagues for the department.

You will work with experienced and engaged colleagues and work closely with many different stakeholders within Novo Nordisk headquarters and affiliates. In this dynamic environment, our dedicated group prepares worldwide regulatory strategies for submissions and is responsible for interactions with regulatory authorities.

The position
As Senior Regulatory Professional in RA Biopharm 2, you will be involved in a variety of regulatory tasks ensuring fast approval of our Clinical Trial Application (CTA’s), marketing authorisation applications and variation applications in Life cycle Management (LCM). This means that you will compile, submit and maintain applications for our product portfolio. You will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions, ensuring high quality input to the regulatory strategies and submissions.

In addition, you will plan, coordinate and review regulatory documentation, chair internal working groups and be our primary RA point of contact for relevant stakeholders within Novo Nordisk.

Qualifications
You hold a scientific Master’s degree within Chemistry, Pharmacy, Engineering or similar, and you have at least 3-5 years of regulatory experience combined with solid analytical skills and knowledge from the pharmaceutical industry or a medicinal agency. Furthermore, you have experience with either CTA applications, marketing authorisation applications or variation applications including labelling.
 
On a personal level, you demonstrate that you are organised, detail-oriented, a proactive problem solver and you enjoy working in a team and project oriented organisation. You communicate well and are completely comfortable speaking and writing in English and preferably also in Danish. In addition, you thrive in busy and changing circumstances and bring a can-do attitude and a healthy sense of humour. You keep focus on jointly moving the projects and are able to work independently, be challenged and find new solutions.

 

Working at Novo Nordisk
At Novo Nordisk we strive for excellence. As a world leader in diabetes care and a major player in haemostasis and hormone replacement therapy, we are proud to make a difference for millions of people around the world. We know that results are made together, and that great opportunities for personal and professional growth are important to provide.

 

Contact
For further information, please contact Henriette Sølver Schou +45 30751807 or Jane Møll Pedersen + 45 30753759 
 

Deadline

30 June 2019, however applications will be read on an on-going basis. 

 

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.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2421

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: Novo Nordisk A/S

source: DK-STAR