Regulatory Affairs CMC GRL, Director Level - This a gloabl role with a growing company in a beautiful part of the world!
Regulatory Affairs Director, CMC GRL – Based in Geneva – EMA & FDA Leadership. Do you want to take the lead for global biological development projects?
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!
If you wish to apply for this role, please send your CV with a covering note to email@example.com or alternatively, to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the London office on +44 (0)20 7801 3380.
Advanced Regulatory is a division of Advanced Search and Selection Ltd and has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas - we have offices both in the UK and in Switzerland. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory Affairs.
We match professional candidates to the best permanent, contract and interim roles in the market. For more information about the company visit us at www.advregulatory.com.
We provide a high level of service because we believe this matters. Regulatory professionals will find we know our recruitment subject matter.
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