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Novo Nordisk

Novo Nordisk
Udefinereret

Senior Regulatory Professional in Regulatory CMC

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. The employees in Regulatory Affairs (RA) have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders simultaneously. 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 CMC Biopharm 2” is part of RA CMC Biopharm 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 14 highly skilled and dedicated people involved in every CMC aspect concerning marketed products and 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 colleague 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 the CMC part of clinical trial applications, marketing authorisation applications and post approval CMC variations. Furthermore the department is responsible for interactions with regulatory authorities.

The position
Depending on your experience you will either work at a development project approaching the submission of a new marketing authorisation application, or work with a product where the first marketing authorisations have been obtained and the focus is on roll out of the product to the rest of the world and Life cycle management (LCM) of the product.
Regardless of the position you will compile, submit and maintain applications for the product you work with. You will be expected to provide regulatory CMC input, be proactive, challenge the discussions and contribute to project team decisions, ensuring high quality CMC 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 regulatory point of contact for the Development, Production and Product Support units in Novo Nordisk.

Qualifications
We expect you to have a Master of Science in Pharmacy or other similar university degree plus experience within regulatory aspects of CMC.
You have a strong interest and good understanding of regulatory guidelines and regulatory affairs and can apply this in your day to day work. Furthermore you have some years of regulatory experience either from the Pharmaceutical industry or from a Medicinal agency.
In addition, it would be valuable if you have a good general knowledge and interest in manufacturing processes for proteins and/or injectable drug products. You are able to communicate scientifically difficult topics related to protein chemistry/analytical chemistry/manufacturing of drug products so it is easy to understand for health authorities and you find this process very interesting.
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, your skills, commitment and ambition help us change lives for the better. In exchange, we offer you a chance to work with extraordinary talent and to develop professionally and personally.

Contact
For further information, please contact Tina Meinertz Andersen at +45 3079 8717.
 
Deadline
31 January 2018

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