Expiry Date: 07-11-2019
Categories Biotech, Clinical Research, Regulatory Affairs
Salary: On Application
Job Type: Full Time
Location: Geneva, Switzerland
This highly efficient and extremely successful medium sized Biotechnology company that has developed a hugely impressive pipeline of large molecule biologicals in mid and late stage of development. There are a number of potential blockbusters due for filling in the EU and USA over the next 1-3 years. As a result my client is now seeking a highly experienced CMC professional with a biological background gained through experience in either EU or US markets to take the lead in setting global strategies and coordinating complex submissions for the US, Europe and major international markets.
This is a highly visible role that requires strong levels of leadership for multiple cross-functional project teams and strong organizational and analytical skills to drive and provide strategic / operational regulatory CMC direction.
Your duties will include responsibility for leading global CMC regulatory strategy for biologic development projects which will include HA meetings and negotiations for FDA and EMA. You will also lead and matrix manage for internal & external teams on assigned projects for the preparation and review of IND/IMPDs, NDA/BLAs and EU and International MAAs.
With this excellent role comes an excellent package which includes: a high level basic salary, bonus, car allowance, full re-location package to beautiful Geneva with expectations that you will take the lead for Global projects.
This a gloabl role, with a growing company in a beautifal part of the world!
To apply for this role, please register on this web site. My team and I would welcome a phone call in private if you would like to explore this role and opportunity, then please contact either myself, Theo Moore, or my colleague Matt Greig, in the London office on +44 (0)20 7801 3384, or at any time during evenings on +44 (0)7918679405.
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