Expiry Date: 25-12-2021
Category Regulatory Affairs
Job Type: Full Time
Département de Paris
My client is already placed to leverage their pipeline and have achieved a full approval for one of their lead compounds. The organization is a niche gene therapy specialist R&D biotech, with a pipeline of more than a dozen targeted diseases all using gene editing / gene therapy as a modality.
The company is smaller, but not too small, and are led mostly from Europe, with a US HQ on the East Coast and their Global HQ here in Europe, in the greater London area.
The role can be hybrid, or remote, and can even be based in France or the UK, for the right candidate.
What I like about this role is:
- It’s a global role, so you will be responsible for the overall global RA strategy, but you will have in matrix a US Liaison to look after your local US submissions and prepare US FDA HA meetings
- The target areas are immune, immune-neuro, rare diseases, genetic disorders, so very high unmet need and where there is a clear need for gene therapy especially in pediatric patient populations
- The development lifecycle of the gene therapies is much smaller than classical clinical development so you do not have to wait around for years to see your program through to completion
- The company’s culture is collegiate, grown up, and matrixed – you will be assigned to your program and be the regulatory voice for both the US and European development pathway and overall regulatory strategy (clinical science is UK based not US)
- You will be backed up by a strong CMC RA team, so this is to focus on clinical and non-clinical, where CMC RA will support you with M3
- Your leadership team have known each other in other companies for a long-time so there are strong bridges already between clinical, technology and regulatory!
In return for the opportunity to work on gene therapy products my client is seeking the following:
- You will have experience of leading strategy evolvement for both the US and European markets
- You will have worked on neuro or rare disease, or neuro-immunology, or gene / cell therapy indications / drugs
- You will be a self-starter, who knows how to weave the best elements of strategy and thinking at the project team level with giving your sub-teams a chance to be involved in shaping thinking or plans
- You will have managed / co- / led HA meetings in more than one region or major market!
- You will enjoy the science of gene therapy as it applies to the patient and want to be part of what I believe will be in not too long a highly successful gene therapy biotech company.
To apply for this role, please press the red “Apply for position” button, or contact Matt Greig on +44 (0)207 801 3386 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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