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Job Details
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Senior Regulatory CMC specialist

Business Type: Pharmaceutical Company, Biotechnology Company, Drug Development Company, Medical Devices Company
Job Type: Biotechnology, Chemistry, CMC, Regulatory Affairs
Job Level: Experienced (non manager)
Position: Full Time
Salary: EUR90000 - EUR110000 per annum
Location: Denmark
Reference: CH. 200636.1
Closing Date: 18/01/19
Job Details:
Senior Regulatory Biological CMC Specalist.
Have you worked with regulatoryCMC for biological products for 5+ years? would you like to be part of establishing and growing a newly formed department? would you like to be a key player when it comes to the companies furtherdevelopment, if the answer where yes, then I got just the thing for you I have just the opportunity for you! You will be Regulatory CMC responsible for the whole CMC package and be part of developing and forming the department as it grows as it''s the most senior specialist The Position
  • Responsible for all Regulatory CMC activities on biopharmaceuticals development projects.
  • Responsible for developing the Regulatory CMC strategy for assigned projects.
  • Driving the preparation of CMC part of IND/IMPD/BLA/MAA''s, authority meeting preparations.
  • Working in close cooperation with colleagues across the organisation, such as Research, Chemical & Pharmaceutical Research and CRO''s
  • Have a central position as an advisor for both Regulatory Affairs and other R&D stakeholders within the biopharmaceuticals field.
  • Be part of Regulatory Affairs teams participating in the development of the global regulatory strategy
  • Educating your colleagues in the department
  • Covering global regulatory requirements with a focus on US, EU, Japan and China
required experience
  • hold a masters degree in life science
  • 5+ years of experience working regulatory Biologic CMC


  • Experience collaborating with Global partners
  • Experience with filling of NDA, MAA and BLA

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.

Posted: 11/01/2019 | NPJ Ref: 228422
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