Regulatory Affairs Program Lead – Visp (CMC/GMP)

Lonza Group Ltd.; Oberwallis; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Benefits dieser Stelle

Agile career

Inclusive workplace

Competitive compensation

Benefits package

Zusammenfassung

Lonza Group Ltd. is seeking a Manager of Regulatory Affairs at our Visp site in Switzerland.

The role leads end-to-end regulatory activities for complex client programs, coordinating timelines and deliverables with global RA networks to ensure timely, compliant regulatory milestones. You will build regulatory strategies aligned with global requirements, support health authority interactions, and drive continuous improvement while balancing compliance and operational feasibility.

Qualifikationen

• Academic degree in Chemistry, Biochemistry, Pharmacy, or a related scientific discipline.
• Experience in GMP-regulated manufacturing in CDMO environments with exposure to QA/QC/Regulatory Affairs or Program/Project Management.
• Ability to translate customer and regulatory requirements into operational execution.
• Strong stakeholder management and communication across functions (QA, QC, MSAT, Production, Supply Chain).
• Experience with regulatory activities (submissions, lifecycle management, health authority interactions) is a strong advantage.

Aufgaben

• Lead end-to-end regulatory activities for Visp client programs as Regulatory Affairs Project Lead.
• Coordinate regulatory workstreams across internal functions and global RA networks.
• Oversee submissions, lifecycle management, and health authority interactions.
• Provide regulatory assessment of changes, deviations, and lifecycle activities.
• Support customers with CMC regulatory topics and strategy; manage relationships with stakeholders.

Kenntnisse

Regulatory leadership

Cross-functional collaboration

Project management

Regulatory submissions

English & German communication

Ausbildung

Bachelor's or higher in Chemistry/ Biochemistry/ Pharmacy or related

Tools

TrackWise

LIMS

Documentum

Veeva

Jobbeschreibung

Lonza Group Ltd. is seeking a Manager of Regulatory Affairs at our Visp site in Switzerland.

The role leads end-to-end regulatory activities for complex client programs, coordinating timelines and deliverables with global RA networks to ensure timely, compliant regulatory milestones. You will build regulatory strategies aligned with global requirements, support health authority interactions, and drive continuous improvement while balancing compliance and operational feasibility.