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Senior Vice President / Vice President of Regulatory Affairs
A pioneering biotech focused on individualized therapies for rare pediatric neurodegenerative conditions is seeking a Senior Vice President / Vice President of Regulatory Affairs. This executive role will lead global regulatory strategy, with a particular focus on the UK and EU, supporting the development of advanced genetic therapies using ASO technologies.
Key Responsibilities
- Lead regulatory strategy and submissions across the UK, EU, and potentially the US
- Liaise with MHRA, EMA, and other authorities to ensure regulatory alignment
- Advise internal stakeholders on regulatory risks and compliance
- Represent the company in external regulatory forums and industry groups
- Scale regulatory operations during rapid organizational growth
Requirements
- 15+ years’ experience in regulatory affairs within pharma/biotech
- Proven leadership in EU/UK submissions and regulatory agency engagement
- Strong background in rare diseases, ASO therapies, or pediatric disorders
- Advanced degree (PhD, PharmD, or MSc) in a scientific discipline
- Experience operating in high-growth environments with global scope
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