Regulatory Affairs Manager

hace 1 día

Madrid, España G&L Scientific A tiempo completo

This role can be based in either our Barcelona, Belfast or London Office. We work on a hybrid basis.Ready to dive into some seriously meaningful science? We’re looking for a seasoned CMC Regulatory Affairs pro who loves complex challenges, global coordination, and shaping regulatory strategy for a high-impact vaccine portfolio. You’ll step in as our Senior Regulatory Strategist, owning several major upcoming submissions—including:Swapping out an in vivo potency assay for a shiny new in vitro methodImplementing new potency reference vaccine replacementsIf 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 a PhD).What You Bring Demonstrable significant experience in CMC Regulatory Affairs—you’ll have bonus points if you’ve wrangled global lifecycle submissions for vaccines.Hands‑on experience with:Register new analytical methodsPotency assay development and validationReference standard strategy and maintenanceA proven track record of leading 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 wheel fast.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.#J-18808-Ljbffr

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