Location: Netherlands (Amsterdam, Hybrid or On-site) | Job Ref: AXRAD008
Overview:
Our client, a pioneering gene therapy developer is hiring a Regulatory Affairs Director to lead global strategy across their ATMP portfolio. Backed by significant funding, the company is entering pivotal studies.
Key Responsibilities:
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Define and execute global regulatory strategies across EU, US, and APAC
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Lead agency meetings including pre-IND and scientific advice
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Oversee CTA and IND submissions and prepare for future BLA/MAA
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Advise internal teams on regulatory timelines, risks, and requirements
Requirements:
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10+ years in regulatory affairs with advanced therapies
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Proven experience with EMA and FDA submissions
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Strong leadership and strategic capabilities
Why Join?
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Join one of Europe’s most promising ATMP developers at a critical growth stage
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Lead global regulatory efforts across high-impact cell and gene therapy assets
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Attractive package with relocation support and equity options
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Work with an expert, mission-driven team dedicated to transforming patient outcomes
Equal Opportunities Employer
Axion is an equal opportunities employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
