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

ppLocation: 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. As a Manager Regulatory Affairs based at our manufacturing site in Visp, 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. You act as a trusted regulatory advisor to cross-functional teams and clients, ensuring proactive risk management, alignment of regulatory expectations, and seamless integration of regulatory requirements into project execution. By orchestrating regulatory activities across functions and geographies, you ensure the high-quality, compliant, and timely delivery of regulatory milestones, 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. /ph3What you will get: /h3ulliAn 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 /ulpThe full list of our global benefits can be also found on /ph3What you will do: /h3h3Project Leadership Regulatory Coordination: /h3pLead end-to-end regulatory activities for assigned Visp client programs. Act as Regulatory Affairs Project Lead, ensuring alignment of regulatory strategy, timelines, and deliverables with overall program objectives. Coordinate regulatory workstreams across internal functions and global RA networks, ensuring seamless execution and transparency. Drive prioritization, planning, and tracking of regulatory deliverables across multiple concurrent programs. /ph3Operational Oversight Execution: /h3pEnsure efficient execution of day-to-day regulatory activities supporting client programs, including submissions, lifecycle management, and health authority interactions. Oversee preparation, review, and delivery of high-quality regulatory documentation (e.g., dossier content, responses to Health Authority queries, briefing packages). Support teams in managing competing priorities and resolving operational challenges in a timely manner. /ph3Regulatory Strategy Compliance: /h3pSupport customers with CMC strategies in alignment with global requirements and customer expectations. Ensure all regulatory activities are compliant with applicable guidelines, registered dossiers, and Lonza procedures. Provide regulatory assessment of changes, deviations, and lifecycle activities, ensuring alignment with regulatory filings and strategy. Ensure consistent interpretation and application of regulatory requirements across projects and technologies. Support the Lonza Regulatory Information Bulletin. /ph3Customer Stakeholder Management: /h3pAct as primary regulatory interface for customers on assigned programs, providing expert guidance on CMC regulatory topics and strategy. Build and maintain strong, trust-based relationships with customers and key internal stakeholders (e.g., MSAT, Quality, Production, Supply Chain). Support customer interactions with Health Authorities, including preparation and participation in meetings and responses. Ensure clear, proactive communication of regulatory risks, timelines, and deliverables to all stakeholders. /ph3Continuous Improvement Regulatory Excellence: /h3pContribute to strengthening regulatory capabilities at the Visp site, ensuring scalability and consistency across programs. Support inspection readiness, ensuring high standards of compliance and documentation. Proactively identify risks and improvement opportunities, implementing mitigation strategies to ensure reliable program delivery. /ph3What we are looking for: /h3ulliAcademic degree in Chemistry, Biochemistry, Pharmacy, or a related scientific discipline /liliSolid experience in the pharmaceutical, chemical, or biotech industry, ideally within CDMO environments and GMP-regulated manufacturing and proven experience in functions such as Quality Control (QC), Quality Assurance (QA), Regulatory Affairs, or Program/Project Management, with strong exposure to manufacturing operations (preferably Small Molecules, Conjugates or related technologies) /liliDemonstrated ability to work in cross-functional, client-driven environments, with a strong understanding of how to translate customer and regulatory requirements into operational execution. /liliGood understanding of GMP regulations, quality systems, and manufacturing processes, with the ability to apply regulatory requirements in a pragmatic, solution-oriented manner /liliExperience contributing to or supporting regulatory activities (e.g. submissions, lifecycle management, change assessments, or health authority interactions) is a strong advantage /liliStrong stakeholder management and communication skills, 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 ownership and accountability in a dynamic CDMO environment and ability to balance compliance, customer expectations, and operational feasibility, ensuring efficient and reliable delivery of program objectives /liliExcellent communication skills in English and German is 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. People 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 /p #J-18808-Ljbffr