pOur client is a leading international pharmaceutical company with a strong portfolio of innovative and established products. To support ongoing lifecycle and remediation activities, we are seeking Regulatory Specialists (CMC) with experience supporting commercial products and post-approval regulatory processes. /ppThis role focuses on lifecycle management, regulatory maintenance, change controls, remediation projects, and data management activities within the Veeva environment. /ppbResponsibilities /b /pulliManage and execute global technical regulatory submissions for commercial products. /liliSupport lifecycle management activities and post-approval maintenance. /liliAssess change controls and determine regulatory impact. /liliManage regulatory deviations and remediation activities. /liliMaintain technical documentation in Veeva and Veeva RIM. /liliSupport legacy data clean-up and system integration initiatives. /liliAct as the regulatory representative within cross-functional project teams. /liliCollaborate with quality, manufacturing, supply chain and regulatory stakeholders. /liliDrive process improvements and identify opportunities to simplify workflows. /liliSupport communications with Health Authorities and external partners. /li /ulpbRequirements /b /ppbMust Have /b /pulliBachelor's degree in a relevant scientific discipline. /lili4+ years of CMC Regulatory Affairs experience. /liliExperience supporting commercialized pharmaceutical products. /liliExperience with post-marketing submissions, lifecycle management, regulatory maintenance and change controls. /liliStrong proficiency with Veeva and Veeva RIM. /li /ulpbNice to Have /b /pulliExperience within a large global pharmaceutical environment. /liliExperience with biologics. /liliExperience with remediation projects and legacy product data clean-up. /liliLocation: Basel area /liliHybrid model with minimum 50% onsite presence /li /ul #J-18808-Ljbffr
Regulatory Specialist (CMC) Commercial Lifecycle & Post-Marketing 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.
