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Senior CMC Specialist

Category:  Regulatory
Location: 

Søborg, Capital Region of Denmark, DK

Regulatory CMC Specialist (monoclonal-antibody expertise)

Are you an ambitious and science-driven regulatory CMC expert with strong monoclonal-antibody experience who wants to work with innovative investigational medicines? 

Are you able to take the lead and drive regulatory strategies for high impact projects? Would you relish the opportunity to work together with decision-makers across multiple functions in a global environment?

If yes, the position as Regulatory Affairs CMC Specialist in our area might be your dream job.


The position
As an RA CMC specialist in our area, you will demonstrate leadership by setting regulatory strategic direction for high impact projects.

 

•  These strategies will ensure that regulatory pathways do not hinder scientific progress.
•  Guiding and mentoring junior colleagues, participating in cross-functional expert panels and contributing to improvements projects. 

•  Further development of Regulatory, Scientific and Management experience. 

 

You will work in a fast-paced environment with tight deadlines and deal with the challenging reality of international communication across time zones, cultures, and circumstances. The atmosphere is informal, and good humour is always welcome. 

This position is based in Søborg, Capital area of Denmark. 


About the department
Novo Nordisk Regulatory Affairs (RA) makes medicine available to patients worldwide by ensuring fast regulatory submissions and approval’s in all our global markets. In RA CMC Biopharm we are a group of 27 highly skilled and dedicated people divided into two departments and involved in every CMC aspect in our Biopharm and Haemophilia products. 

The early and late-stage project portfolio is rapidly evolving; therefore we are expanding our team and looking for a senior colleague specialised in regulatory CMC strategies for Monoclonal Antibodies, Advanced Therapy Medicinal Products (ATMPs), Cell and Gene Therapy products and other protein-based biologics. 


Qualifications

•    MSc and/or Ph.D in Biochemistry, Pharmaceutical Sciences or similar discipline/degree. 
•  Advanced experience from the pharmaceutical industry, preferably including Senior CMC experience either from the pharmaceutical industry or from a medical agency.
•    A solid scientific and technical mindset and a thorough understanding of related pharmaceutical operations (e.g. manufacturing, process development, analytics, and quality assurance).
•    Ability to communicate topics related to protein chemistry/analytical chemistry/manufacturing of drug substances and drug products scientifically and professionally.
•    Strong Communication skills in Written and Spoken English.


Working at Novo Nordisk 

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop; we seize them. From research and development through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

 

Contact
For further information please contact Nicolai Listov-Saabye +45 3075 4135 

 

Deadline
Please apply for the position no later than 5th October 2021

 

•    You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your CV.
•    In addition, please avoid the use of photos in your CV. This makes for a better and fairer process. 

 

Please be aware that we will be reviewing incoming applications after the deadline due to System Maintenance Shutdown period.

 

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Millions rely on us 

At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize 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 to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.