Overview In this role you lead regulatory activities for Visp client programs, shaping strategies that enable development, manufacturing, and commercialization. You act as a regulatory advisor to cross-functional teams, aligning expectations and ensuring timely regulatory milestones. You manage interactions with health authorities and coordinate global RA workstreams to deliver high-quality dossiers and responses. The position strengthens Lonza’s capability as a partner of choice for complex molecules and bioconjugation programs. You will work in an agile, collaborative environment with a strong focus on compliance and risk management. Leistungen / Benefits agile career and dynamic culture inclusive and ethical workplace competitive compensation programs role- and location-dependent benefits relocation assistance for eligible candidates and families variety of benefits across roles and locations Verantwortungsbereiche Lead end-to-end regulatory activities for Visp client programs and align strategy with program objectives Coordinate regulatory workstreams across internal functions and global RA networks Plan, track, and prioritize regulatory deliverables across multiple programs Oversee submissions, lifecycle management, and health authority interactions Prepare and review regulatory documentation and briefing materials Support customers with CMC strategies aligned to global requirements Maintain strong stakeholder relationships with internal teams and customers Contribute to regulatory excellence, inspection readiness, and continuous improvement Zentrale Anforderungen Academic degree in Chemistry, Biochemistry, Pharmacy, or related field Experience in pharmaceutical/chemical/biotech industry, ideally in CDMO environments and GMP manufacturing Background in QA/QC/Regulatory Affairs or Program/Project Management with manufacturing exposure Strong understanding of GMP, quality systems, and manufacturing processes Experience with regulatory activities (submissions, lifecycle management, health authority interactions) is advantageous Excellent English and German communication; familiarity with regulatory systems is a plus Cross-functional collaboration Strong communication Ownership and accountability GMP regulatory knowledge Health authority interactions TrackWise, LIMS, Documentum, Veeva (advantage)
Regulatory Affairs Manager (f/m/d) Arbeitgeber: Lonza
Lonza ist ein hervorragender Arbeitgeber, der eine dynamische Arbeitskultur und flexible Arbeitsmöglichkeiten bietet, um die besten Talente zu fördern. Mit einem starken Fokus auf persönliche Entwicklung und Teamarbeit ermöglicht Lonza seinen Mitarbeitern, ihre Karriere in einem bedeutenden Bereich wie der internen Revision voranzutreiben, während sie gleichzeitig zur Verbesserung von Millionen von Leben beitragen. Die enge Zusammenarbeit vor Ort fördert nicht nur den Austausch von Ideen, sondern auch die technische Präzision, die für die Herstellung von Arzneimitteln erforderlich ist.
