Regulatory Affairs Leader – Complex Programs

Lonza; Basel; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile culture

Inclusive workplace

Compensation programs

Benefits package

Zusammenfassung

Lonza in Visp, Switzerland, seeks an experienced Manager Regulatory Affairs to lead end-to-end regulatory programs at the manufacturing site. You will shape regulatory strategies, coordinate cross-functional teams, and ensure timely delivery for complex projects, including health authority interactions and lifecycle activities.

The role requires a strong background in GMP environments, excellent stakeholder management, and fluency in English with German as an advantage.

Qualifikationen

• Academic degree in Chemistry, Biochemistry, Pharmacy, or related discipline.
• Solid experience in pharmaceutical, chemical, or biotech industry, ideally within CDMO environments and GMP manufacturing.
• Experience in cross-functional, client-driven environments with understanding of GMP, quality systems, and manufacturing processes.
• Experience contributing to regulatory activities (e.g., submissions, lifecycle management, health authority interactions) is a strong advantage.
• Strong stakeholder management and communication skills; ability to collaborate across QA, QC, MSAT, Production, and Supply Chain.
• Excellent command of English; German is an advantage; familiarity with TrackWise, LIMS, Documentum or Veeva is a plus.

Aufgaben

• Lead end-to-end regulatory activities for Visp client programs.
• Act as Regulatory Affairs Project Lead, aligning strategy, timelines, and deliverables with program objectives.
• Coordinate regulatory workstreams across internal functions and global RA networks.
• Drive prioritization, planning, and tracking of regulatory deliverables across multiple programs.
• Oversee preparation, review, and delivery of regulatory documentation and health authority responses.
• Support lifecycle management, inspections readiness, and regulatory compliance across projects.

Kenntnisse

Regulatory leadership

CMC strategy

Cross-functional leadership

Regulatory submissions

Health Authority liaison

Project management

GMP knowledge

English & German

Ausbildung

Academic degree in Chemistry, Biochemistry, or Pharmacy

Tools

TrackWise

LIMS

Documentum

Veeva

Jobbeschreibung

Lonza in Visp, Switzerland, seeks an experienced Manager Regulatory Affairs to lead end-to-end regulatory programs at the manufacturing site. You will shape regulatory strategies, coordinate cross-functional teams, and ensure timely delivery for complex projects, including health authority interactions and lifecycle activities.

The role requires a strong background in GMP environments, excellent stakeholder management, and fluency in English with German as an advantage.