Expiry Date: 24-12-2020
Category Regulatory Affairs
Job Type: Full Time
Regulatory CMC Lead ** Lead MAA/BLA for Gene / Cell Product
Note: This role can be graded as Director or Associate Director and can be located in a number of places including nr Boston area, MA, or RTP in NC, in Switzerland or the United Kingdom (but you will need to have prior US BLA experience!). A full relocation package is available and some home working might be available depending upon your level, capability and location.
About My Client
This is a true success story of the biotechnology industry, a company which is more than doubled in size by T/O every five years for the last near 20 years, without doubling their headcounts, because they are agile thinkers, have strong science / data and have been almost puritanical in focusing on their patients by investing and developing numerous 1st in Class Novel treatments, and by carefully outsourcing (say for authoring or routine / transactional submissions).
This organization have several high value patient assets, combined with one of the most novel pipelines in industry, and this particular role focuses on a Cell and Gene therapy products coming through including a late phase program you will be assigned to.
About You! Why Consider This Role?
You will consider yourself a ‘High Performer’, most likely in a US-focused role, with prior US BLA CMC RA strategy / build / filing track record and you have spent the last couple of years working on a Lenti, AAV, or CAR-T molecule but now want to join a role where you can build out your US expertise in to a ‘Global RA CMC strategy’ position (with a direct filing in the next 12-18 months).
You will consider yourself to have the drive combined with the communication skills and matrix leadership to facilitate brining a cell / gene therapy product over the finishing line, ie, deliver the BLA/MAA for M2.x/3 through to submission and review (knowing that they have strong clinical data).
You will be supported by an individual who is very collaborative, wants a strong leader, not a pure follower, and has won awards personally for their values and pro bono activities. They will help you engage with the teams and settle in, in a company which is very ‘can-do’, and a product which is very cutting edge. You will have a RA CMC liaisons in other regions, who have prior Cell and Gene Therapy experience.
My client is willing to meet and then increase your existing package to engage you. The packages are location dependant but high-end, more than most per grade, and the roles come with a bonus, RSU based stock plan, and a significant package of measures if we have to buyout LTIP.
To apply for this role, please press the red “Apply for position”, or contact me, Matt Greig, on my US number 908-332-9157, or if you are dialling from Europe, please call my UK number on +44 207 801 3386 - I take calls from 7 am Eastern US time to 4.30 pm daily as well as Saturday and Sunday AMs.
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