Director, Global Regulatory Strategy

\n Join a Leading Biopharmaceutical Innovator as Director, Global Regulatory Strategy\n

Are you a seasoned regulatory expert with a passion for bringing life-changing therapies to patients worldwide? We are seeking a dynamic and experienced Director of Global Regulatory Strategy to lead pivotal regulatory activities in the neurology space. This high-impact role offers the opportunity to shape regulatory pathways, interact with top-tier agencies like the EMA, and influence the future of innovative medicines. As a key member of our international team, you will drive strategic regulatory initiatives, ensure compliance, and support the successful development and approval of groundbreaking products across Europe, the US, and beyond.

What You’ll Need to Succeed:\n

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• A bachelor’s degree in a relevant field.
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• Extensive industry experience in Regulatory Affairs within the biotech/biopharmaceutical sector.
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• Proven success in managing Clinical Trial Applications and product registration dossiers.
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• Demonstrated ability to collaborate effectively with regulatory agencies such as EMA and national authorities.
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• Experience leading Scientific Advice interactions and developing regulatory strategies aligned with corporate objectives.
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• Strong understanding of pharmaceutical regulations worldwide, with a focus on European requirements.
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• Excellent communication skills, with the ability to influence and negotiate with regulatory bodies and internal teams.
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• Strategic thinker with operational excellence in planning and project management.
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Nice to Have Skills:\n

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• Experience with Pediatric Investigation Plans.
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• Global regulatory leadership, including acting as a Global Regulatory Lead for products.
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• Prior experience in neurology or biologics/biotechnology segments.
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Preferred Education & Experience:\n

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• A minimum of an undergraduate degree in life sciences, pharmacy, or a related discipline.
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• Significant industry experience demonstrating progressive responsibility in Regulatory Affairs, ideally in a global and cross-functional context.
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Other Requirements:\n

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• Ability to build strong interpersonal relationships across global teams and regulatory agencies.
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• An innovative mindset capable of navigating a rapidly evolving regulatory landscape.
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