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Regulatory Affairs Manager – Biotech – HQ in Stockholm, Stockholm

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Location:

Stockholm, Sweden 

Job Category:

Healthcare
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EU work permit required:

Yes
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Job Reference:

288064 1_1623165882

Job Views:

45

Posted:

08.06.2021

Expiry Date:

23.07.2021
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Job Description:

Regulatory Affairs Manager – Biotech – HQ in Stockholm

Would you like to work for an expanding biotech company headquartered in Stockholm?

The company

My client is a small, but ambitious biotech company with several candidate drugs in clinical development. They develop improved and generic version of previously marketed drugs with a focus on protein kinase inhibitors used for cancer treatment.

They now need a Regulatory Affairs Manager to join a small team of experts to help get market approval for their drugs. If you’re looking to play a vital role in a company’s efforts to gain market approval and growing to a key player in their niche market this might just be the position for you.

Job tasks

* Participate in mapping the global operational regulatory strategy
* Liaise with government contacts; primarily the FDA
* Participate in planning, preparation and delivery for approvals of global clinical trials
* Create and update SOP's, quality control documents and templates
* Handle clinical and CMC documentation in the dossier



Requirements

* At least 5 years of regulatory experience with a focus on either CMC or clinical regulatory affairs
* A life-science degree within a relevant field
* Good understanding of regulatory requirements within the EU and US
* Fluency in both English and Swedish



For a confidential discussion please get in touch with Johan Jakobsen by submitting your CV to J.Jakobsen@nonstop-recruitment.com or by giving me a call at +45 787 94 740, my personal extension is 3501.

If this does not sound like the role for you, but you know someone that might be interested, please forward this ad to them so they don’t miss out on a great opportunity! The application is open until the end of Friday 18/06/2021, but don’t wait up as my client is arranging interviews swiftly and need the position filled as soon as possible.

NonStop is one of the largest and fastest growing specialised life sciences 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, Germany, Luxembourg, Romania, and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

Job Requirements:

* At least 5 years of regulatory experience with a focus on either CMC or clinical regulatory affairs * A life-science degree within a relevant field * Good understanding of regulatory requirements within the EU and US * Fluency in both English and Swedish
Company Info
NonStop Consulting
25 Canada Square, Canary Wharf
London, United Kingdom
Phone: +44 0207 234 0550
Web Site: www.nonstopconsulting.com
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