Expiry Date: 24-02-2023
Categories Biotech, Regulatory Affairs
Salary: On Application
Job Type: Full Time
Location: US Remote – Options to be based US Wide (HQ on EST)
We have a great opportunity available to join an established and still growing Cell and Gene Therapy company focused on CRISPR, who have released great data for their early development pipeline. They have a mixed portfolio across a number of disease and therapy areas, including Rare Diseases, Oncology and Immunology and the company has a market capital of almost $4billion already.
As Director of Regulatory Strategy, you will have a strong and pivotal position where you will be both strategic and hands-on in a role that will allow you to make an impact in the right way. You will assume direct point of contact with health authorities, lead transparent and proactive interactions with global health authorities, and manage the preparation and submission of high-quality dossiers and clinical trial applications in the US, EU, Japan, and ROW. This is a highly collaborative and positive environment, and the role will require high level cross-functional interactions, excellent writing skills, as well as a good grasp of the underlying science (gene or cell-based therapeutics, RNA-based therapeutics, and/or orphan drug development).
The Regulatory Affairs group is a rapidly growing team and includes professionals with diverse regulatory expertise in both large pharma and small biotech settings. You will report to the Sr. Director Regulatory Affairs and the ideal candidate will be a strategic thinker, with an innovative approach to collaboration and a passion for delivering the regulatory message to different departments, as this will be critical to your success as a leader in this role.
Our client has a passion for delivering medicines that can positively transform the lives of people living with severe and life-threatening diseases, and if you share this passion and have a strong regulatory background in development, major submissions and have experience with global regulatory health authorities (e.g. FDA, EMA) then we would like to hear from you. On offer is a strong package including a competitive basic salary, good bonus and an exceptional and extremely lucrative RSU package.
To apply for this role, please contact me, Theo Moore on US 587 216 9302 or my colleague Ivan Nash on US 908 378 8980 or send a full CV to Ivan.Nash@AdvTalent.com and we will reply by return. We will support you throughout the interview and on-boarding experience.
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