pOur client is a global leader in the pharmaceutical industry, committed to advancing science and delivering innovative therapies to patients worldwide. To support ongoing clinical development activities, we are looking for a Regulatory Specialist (CMC) with experience in early-stage development and clinical regulatory submissions. /p /brpIn this role, you will support global CMC regulatory activities for investigational products, working closely with cross-functional teams to ensure high-quality submissions and successful interactions with Health Authorities. /p /brh3Responsibilities /h3 /brulliManage and execute global technical regulatory submissions for clinical-stage products. /liliSupport the preparation and maintenance of Investigational Medicinal Product Dossiers (IMPDs) and related documentation. /liliContribute to Clinical Trial Applications (CTAs) and other early-phase regulatory submissions. /liliAssess regulatory impact of technical changes and maintain documentation in Veeva. /liliAct as a key regulatory representative within cross-functional project teams. /liliCollaborate with development, manufacturing, quality, and regulatory stakeholders globally. /liliSupport Health Authority interactions and regulatory communications. /liliMonitor evolving regulatory requirements and evaluate potential impacts on development programs. /li /ul /brh3Requirements /h3 /brh3Must Have /h3 /brulliBachelor's degree in a relevant scientific discipline. /lili3-4+ years of CMC Regulatory Affairs experience. /liliExperience supporting IMPs, IMPDs and Clinical Trial Applications (CTAs). /liliExperience with technical regulatory submissions for clinical development programs. /liliStrong knowledge of Veeva Document Management. /li /ul /brh3Nice to Have /h3 /brulliExperience within a large global pharmaceutical environment. /liliExperience with biologics. /liliLocation: Basel area /liliHybrid model with minimum 50% onsite presence /li /ul #J-18808-Ljbffr
Regulatory Specialist (CMC) Clinical Development Arbeitgeber: Actalent
Actalent ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Burnsville, Minnesota, eine dynamische und kollaborative Arbeitsumgebung bietet. Mit einem starken Fokus auf technische Exzellenz und kontinuierliche Verbesserung ermöglicht das Unternehmen seinen Mitarbeitern, an innovativen Projekten im Bereich der Luft- und Raumfahrttechnik zu arbeiten und sich beruflich weiterzuentwickeln. Die angebotenen Vorteile, einschließlich flexibler Arbeitszeiten, umfassender Gesundheitsleistungen und einer 401(k)-Rentenplanung, tragen dazu bei, dass Mitarbeiter sich geschätzt und unterstützt fühlen.
