Global Regulatory Affairs Program Lead (CMC)

Lonza Group; Oberwallis; Hybrid; CHF 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Agile career culture

Inclusive workplace

Competitive compensation programs

Site in Visp, Switzerland

Zusammenfassung

Lonza Group in Visp, Switzerland, is seeking a Manager Regulatory Affairs to lead end-to-end regulatory activities for complex client programs at the Visp site. You will shape regulatory strategy and ensure timely, compliant delivery across global networks.

You will act as trusted regulatory advisor to cross-functional teams, coordinating submissions, lifecycle activities, and health authority interactions, with emphasis on GMP and CMC strategies.

Qualifikationen

• Academic degree in Chemistry, Biochemistry, Pharmacy, or related scientific discipline.
• Solid experience in pharmaceutical, chemical, or biotech industries with GMP manufacturing.
• Experience in Quality Control/QA/Regulatory Affairs or Program/Project Management.
• Strong cross-functional collaboration and client-facing communication.
• Knowledge of GMP regulations, quality systems, and manufacturing processes.

Aufgaben

• Lead end-to-end regulatory activities for Visp client programs.
• Act as Regulatory Affairs Project Lead; align strategy, timelines and deliverables.
• Coordinate regulatory workstreams across internal functions and global RA networks.
• Drive prioritization, planning, and tracking of deliverables across programs.
• Oversee submissions, lifecycle management, and health authority interactions.
• Prepare and review regulatory documentation and responses to queries.
• Provide regulatory assessment of changes and lifecycle activities.

Jobbeschreibung

Lonza Group in Visp, Switzerland, is seeking a Manager Regulatory Affairs to lead end-to-end regulatory activities for complex client programs at the Visp site. You will shape regulatory strategy and ensure timely, compliant delivery across global networks.

You will act as trusted regulatory advisor to cross-functional teams, coordinating submissions, lifecycle activities, and health authority interactions, with emphasis on GMP and CMC strategies.