Senior Regulatory Strategist

hace 2 semanas

Madrid, España G&L Scientific A tiempo completo

This role can be based in either ourBarcelona,BelfastorLondonOffice. We work on a hybrid basis.Ready to dive into some seriously meaningful science? We’re looking for a seasonedCMC Regulatory Affairs prowho loves complex challenges, global coordination, and shaping regulatory strategy for a high-impact vaccine portfolio. You’ll step in as ourSenior Regulatory Strategist, owning several major upcoming submissions—including: Swapping out anin vivo potency assayfor a shiny newin vitro method Implementing newpotency reference vaccinereplacementsIf leading cross-functional teams, navigating global health authorities, and crafting impeccable regulatory dossiers sounds like your kind of adventure, read on. Education Master’s degree or higher in chemistry, pharmacy, biology, or similar (we’ll be extra impressed if you have aPhD). What You Bring 8+ yearsin CMC Regulatory Affairs—bonus points if you’ve wrangled global lifecycle submissions for vaccines. Hands-on experience with: Registeringnew analytical methods Potency assaydevelopment and validation Reference standardstrategy and maintenance A proven track record ofleading multiple projects, shaping CMC regulatory strategy, and authoring major submissions (BLAs, MAAs, variations—your bread and butter). Deep understanding of how vaccines are developed, manufactured, tested, and shipped. Fluency in global CMC frameworks: EMA, FDA, WHO, and friends. Confidence and skill in influencing, negotiating, and keeping everyone—from internal teams to regulators—aligned and energized.✨Who You Are Someone who can jump into a new environment and take the wheelfast. A natural organizer with top-tier project management and multitasking superpowers. An excellent communicator who can bring clarity to complex topics. Empathetic, collaborative, and adept at navigating a multi-cultural, multi-disciplinary matrix (no small feat). A relationship-builder who can negotiate without friction and keep the goodwill flowing.

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