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Job Details
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Regulatory CMC Director



Business Type: Pharmaceutical Company, Biotechnology Company, Drug Development Company
Job Type: Biotechnology, Chemistry, CMC, Regulatory Affairs
Job Level: Management
Position: Full Time
Salary: EUR90000 - EUR110000 per annum
Location: Switzerland
Reference: CH. 201919.1
Closing Date: 11/02/19
Job Details:
Regulatory Biological CMC Director!

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 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 director for the area. there will at first not be any line management, but as the position grows, then you might take online management for multiple people. The Position
  • Provides global leadership regarding management of submission CMC related
  • documents, CMC regulatory data and archiving for Biosimilars.
  • As Business partner to the Biosimilar CMC team develops, supervises and manages
  • the CMC regulatory activities and CMC submission strategy of Biosimilar dossiers and submissions that best serve the biosimilars business needs and ensure compliance with the regulatory systems.
  • Ensures that Biosimilars Business uses the GR&QA Regulatory Information as well as Document and Submission Management System and liaise with the GRA Regulatory Informatics & Submission Management group.
  • Translate CMC data in regulatory CMC positioning in order to create a comprehensive storyline and CMC dossier
required experience
  • hold a masters degree in life science
  • 5+ years of experience working regulatory Biologic CMC

Preferred

  • 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.



NonStop Recruitment Posted by:: NonStop Recruitment (View all our vacancies)
Unless otherwise stated, if applying for a job, you must ensure that you are already authorised to work in the country in which the job is based
Posted: 04/02/2019 | NPJ Ref: 229752
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