Expiry Date: 21-06-2022
Categories Biotech, Regulatory Affairs
Salary: On Application
Job Type: Full Time
Département de Paris
About My Client & Their Opportunity
My client is different because they not only have an actual pipeline of several NBEs that fall into Cell and Gene Therapies IMPDs which cross 3 different novel modalities (think Viral Vectors, a touch of ribonucleic and throw in some ASOs) and you will see why we like this, from a scientific perspective, this role offers not just new modalities, but a broad spectrum of these.
The company is smaller and could be described as being in their infancy, similar to other companies in the past which targeted rare and inherited diseases, however, they already have 4 licensed products, registered in the last 2-3 years, so this company is not just developing their ATMPs, they are expanding both in market terms and in footprint, and this role is critical to their progress, because it is spearheading the Regulators engagement in Europe for Regulatory CMC for their new modality products.
Hence, this role is to lead the EU interactions with the EMA for regulatory CMC for several in a company where the MSAT and Technical teams are in East Coast, and we want someone who can stand on their own two feet, is an independent thinker, but has the technical and scientific skills to influence and shape global strategy while maintaining the watching brief on the European regulatory framework, agency interactions and submissions readiness for IMPDs, MAAs / ATMPs M3, as well as support 3 of their NMEs make it into Ph 3 and eventual full MAA filing.
About Your Experience
You will most likely have a higher degree in a Biotechnology field, or Molecular or Cellular Biology or Bio Engineering. You might have spent time in a MS&T field before moving into regulatory, you will definitely have already worked in regulatory and devised regulatory strategies for the CMC plan for IMPs in Ph 1-3, and have prepared / or reviewed / filed QoS M3 for MAAs or BLAs or ATMPs, and will have understanding of the complexity and requirements for filing Viral Vectors. For this reason you might have a therapeutic medicines or vaccine background in regulatory affairs.
You will be the main POC for CMC questions in Europe, and as such you will be used to managing these level of contact, and know how to drive responses to questions, develop engagement with both the internal teams (Technical, Manufacturing, Quality, Therapy Regulatory) and externally.
Any ex Regulator experience would be useful.
Package & Relocation
A relocation package is open to anyone with EU Citizenship or who are based in Switzerland already. You will receive full support for moving and tax registration. The package is decent, top end, and comes with both a stock option / stock package, as well as a high end bonus. The role is based in easy commute of France and Germany, so you could cross border for this role.
To apply for this role, please contact me, Javier Monfort or my colleague Christian on Swiss number +41 41 562 01 51 or press the red “Apply for position” button, or send a full CV to firstname.lastname@example.org. We will support you throughout the interview and on-boarding experience.
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