Regulatory Affairs Manager (f/m/d) in Raron

pbLocation: the actual location of this job is in Visp, Basel, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. This is a temporary position for a period of one year. /b /ppAs a bManager Regulatory Affairs based at our manufacturing site in Visp /b, you provide end-to-end regulatory leadership for complex client programs supported by the site. You are accountable for shaping and executing robust regulatory strategies that enable efficient development, manufacturing, and commercialization. /ppYou act as a btrusted regulatory advisor to cross-functional teams and clients /b, ensuring proactive risk management, alignment of regulatory expectations, and seamless integration of regulatory requirements into project execution. /ppBy orchestrating regulatory activities across functions and geographies, you ensure the bhigh-quality, compliant, and timely delivery of regulatory milestones /b, strengthening the Visp site’s ability to execute complex programs and enhancing Lonza’s position as a manufacturer of choice for highly complex molecules including bioconjugation projects. /ppbWhat you will get: /b /pulliAn agile career and dynamic working culture /liliAn inclusive and ethical workplace /liliCompensation programs that recognize high performance /liliA variety of benefits dependent on role and location /li /ulpbProject Leadership Regulatory Coordination: /b /pulliLead end-to-end regulatory activities for assigned Visp client programs. /liliAct as Regulatory Affairs Project Lead, ensuring alignment of regulatory strategy, timelines, and deliverables with overall program objectives. /liliCoordinate regulatory workstreams across internal functions and global RA networks, ensuring seamless execution and transparency. /liliDrive prioritization, planning, and tracking of regulatory deliverables across multiple concurrent programs. /li /ulpbOperational Oversight Execution: /b /pulliEnsure efficient execution of day-to-day regulatory activities supporting client programs, including submissions, lifecycle management, and health authority interactions. /liliOversee preparation, review, and delivery of high-quality regulatory documentation (e.g., dossier content, responses to Health Authority queries, briefing packages). /liliSupport teams in managing competing priorities and resolving operational challenges in a timely manner. /li /ulpbRegulatory Strategy Compliance: /b /pulliSupport customers with CMC strategies in alignment with global requirements and customer expectations. /liliEnsure all regulatory activities are compliant with applicable guidelines, registered dossiers, and Lonza procedures. /liliProvide regulatory assessment of changes, deviations, and lifecycle activities, ensuring alignment with regulatory filings and strategy. /liliEnsure consistent interpretation and application of regulatory requirements across projects and technologies. /liliSupport the Lonza Regulatory Information Bulletin. /liliAct as primary regulatory interface for customers on assigned programs, providing expert guidance on CMC regulatory topics and strategy. /liliBuild and maintain strong, trust-based relationships with customers and key internal stakeholders (e.g., MSAT, Quality, Production, Supply Chain). /liliSupport customer interactions with Health Authorities, including preparation and participation in meetings and responses. /liliEnsure clear, proactive communication of regulatory risks, timelines, and deliverables to all stakeholders. /li /ulpbContinuous Improvement Regulatory Excellence: /b /pulliContribute to strengthening regulatory capabilities at the Visp site, ensuring scalability and consistency across programs. /liliSupport inspection readiness, ensuring high standards of compliance and documentation. /liliProactively identify risks and improvement opportunities, implementing mitigation strategies to ensure reliable program delivery. /li /ulpbWhat we are looking for: /b /pulliAcademic degree in Chemistry, Biochemistry, Pharmacy, or a related scientific discipline /liliSolid experience in the pharmaceutical, chemical, or biotech industry, ideally within bCDMO environments and GMP-regulated manufacturing /band proven experience in functions such as bQuality Control (QC), Quality Assurance (QA), Regulatory Affairs, or Program/Project Management /b, with strong exposure to manufacturing operations (preferably Small Molecules, Conjugates or related technologies) /liliDemonstrated ability to work in bcross-functional, client-driven environments /b, with a strong understanding of how to translate customer and regulatory requirements into operational execution. Good understanding of bGMP regulations, quality systems, and manufacturing processes /b, with the ability to apply regulatory requirements in a bpragmatic, solution-oriented manner /b /liliExperience contributing to or supporting bregulatory activities (e.g. submissions, lifecycle management, change assessments, or health authority interactions) /b is a strong advantage /liliStrong bstakeholder management and communication skills /b, with the ability to collaborate effectively across functions (e.g. QA, QC, MSAT, Production, Supply Chain) and interact confidently with customers /liliStructured, proactive, and solution-oriented working style with a strong sense of bownership and accountability in a dynamic CDMO environment /band ability to bbalance compliance, customer expectations, and operational feasibility /b, ensuring efficient and reliable delivery of program objectives /liliExcellent communication skills in English and Germanis an advantage and experience with relevant systems (e.g. TrackWise, LIMS, Documentum, Veeva) is an advantage. /li /ulpEvery day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. /ppPeople come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. /p #J-18808-Ljbffr