Regulatory Affairs Manager (f/m/d)

As a Manager Regulatory Affairs based at the 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.

• Lead 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.
• Ensure 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.
• Support 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.
• Act 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.
• Contribute 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.