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Global Regulatory Affairs - CMC, copenhagen



copenhagen, Denmark 

Job Category:



€90,000.00 - €100,000.00

EU work permit required:


Job Reference:

CH. 199575.2_1539342160

Job Views:




Expiry Date:


Job Description:

Global Regulatory Affairs Professional -CMC BioPharma

Have you worked with regulator life-cycle management activities for biological products? then I have just the opportunity for you!

You will be Regulatory responsible for our global regulatory activities throughout the life cycle of our products growing portfolio, including development and registration as well as market expansions and CMC lifecycle activities in 50 countries worldwide.

The company is currently going through a major process where it is finding its own place in the market and going leaner together with scaling up and redefining how it operates, so if you are looking for a company where you can be part of defining its further and its process in a dynamic setting where there will be plenty of room development, then this is your chance!

You will be joining a growing team of 17 dedicated colleagues with high ambitions. The team is comprised of young and old and forms a strong backbone of academic know how, so you will be able to enjoy training from some of the strongest academic profiles in the sector, to strengthen your profile

The Position

* Planning, coordinating and executing global regulatory submission activities for assigned products
* Writing, compiling and reviewing regulatory CMC submissions
* Provide regulatory CMC expertise to colleagues the company
* Perform regulatory impact assessment of CMC change controls; ensure adequate documentation is generated to support the change and that the variation is approved by regulators worldwide
required experience

* relevant degree in life science or pharmacy
* 3+ years of experience working with Pharma regulatory affairs ideally within CMC of biologics.


* Experience collaborating with EMA and FDA
* Experience with filling of NDA and MAA

If you are interested, then get in touch with, Casper Skyum Hogh by applying below.
You can also connect with me on LinkedIn and send your Cv to me in a word format on the email found on my profile or find more opportunities that we have available on Nonstop’s website

I am a specialised recruiter within Regulatory affairs and medical affairs in the Pharma, Biotech and Medical Device industry. I, therefore, have access to an extensive network within these industries, which aren't available otherwise. If the above opportunity doesn't have your interest, but you would like to hear more about potential opportunities, then you are welcome to contact me for a noncommittal, confidential chat.

If you know someone in your network who may be interested in the above, then you are more than welcome to pass on my details to them, so that I can be of assistance to them.

NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic, and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.
Company Info
NonStop Recruitment
25 Canada Square, Canary Wharf
London, United Kingdom
Phone: +44 0207 234 0550
Web Site:
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