Expiry Date: 12-07-2021
Category Regulatory Affairs
Job Type: Full Time
OPTION SUISSE *** Associate Director / Director *** EU Liaison ** Lead MAAs for a top 5
High performers will find these roles of interest as we have lead compounds in Oncology and Rheumatology that will start to read out, requiring star performers to jump in and take the NME through pre-subs and submission, so if you consider yourself as one of these, please read on!
My client is a well-known innovative and prestigious biopharma, ranked in the top 5 worldwide, and with many well-known products in Oncology, Cardio, Immunology and Neurology. What set’s them apart is although they are large, the teams are distributed in Europe and have a close-knit team, led by highly accomplished Senior Directors and Executive Directors, and my client is not in Basel (FR speaking area).
Global tend to let the European team innovate the EU strategy as their focus is drawn generally to the more adaptive US pathways, aligning TPP between the regions, and supporting the international majors than doing your EU regulatory strategy job for you.
You will work closely with transversal and translation medicines and project teams, US and international Leads, the commercialization groups, as this role spans FTIH to Ph 3a/b, and major new lifecycle (label and line extensions). CMC is prepared by another group!
You will lead the EU sub-teams for strategy, review and submission CTA, VHPs, PIP/PIP Waivers, MAAs/Line Extensions, as well as prepare and lead regulatory authority interactions, with the EMA, major HAs (PEI, ANSM, etc), as well as lead negotiations for agreement of optimal labelling. In regulatory terms, you are the accountable person for HA interactions, senior leadership might be there, but as a support to you. The line manager is an Executive Director, highly affable, capable and engaging. He would like someone with the thinking and capability to work independently.
The company tend to reward extremely well for merit and performance - their bonus scheme is more open-ended, and their stock plan is quick vesting. The role depending upon grade, comes with an attractive salary package.
NOTE! My client is willing to consider stock buy out, certainly, 12-18 months of losses, as well as any lost bonuses!
To apply for this role, please contact Matt Greig on +44 7918 679 405 or Oli Dimitrov on +44 207 801 3388 - alternatively, please send a full CV to firstname.lastname@example.org and we will reply by return. Alternatively, please press the red “Apply for position” button and follow the registration process.
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