Regulatory Affairs Lead — Basel Relocation

C115 (FCRS = CH115) Sandoz Pharmaceuticals AG; Rotkreuz; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Sandoz Pharmaceuticals AG seeks a temporary Specialist to lead the Regulatory Affairs workstream for relocating the Swiss office from Rotkreuz to Basel. You will own end-to-end address changes across Swiss-market artworks and manage related regulatory submissions where applicable.

The role requires cross-functional leadership, solid RA experience, and fluent German and English. The assignment spans 24 months with a focus on delivery, compliance, and audit-ready documentation.

Qualifikationen

• Bachelor’s degree in biomedical, life or pharmaceutical sciences, or an equivalent qualification with substantial relevant regulatory experience; a postgraduate qualification is desirable.
• 3+ years of relevant pharmaceutical Regulatory Affairs experience, including independent management of lifecycle changes and cross-functional implementation projects.
• Fluent German and English, both written and spoken; French and Italian are desirable.
• Hands-on experience managing Swissmedic submissions and lifecycle changes, with sound knowledge of Swiss regulatory requirements and packaging/artwork approval workflows.

Aufgaben

• Lead the address-change workstream, defining the regulatory implementation plan, priorities, responsibilities and milestones in alignment with local RA and the relocation program.
• Oversee updates and regulatory review of packaging texts and related product information, including affected language versions, ensuring consistency of Basel address and approvals.
• Assess Swissmedic submission requirements and manage preparation, review and submission of address-change applications or notifications.
• Lead artwork workflows from change initiation through review and approval of revised artwork, aligning with QA, Supply and manufacturing or packaging sites.

Kenntnisse

German language

English language

Cross-functional leadership

Regulatory thinking

Ausbildung

Bachelor’s degree in biomedical, life or pharmaceutical sciences

Postgraduate qualification desirable

Tools

SAP

Jobbeschreibung

Sandoz Pharmaceuticals AG seeks a temporary Specialist to lead the Regulatory Affairs workstream for relocating the Swiss office from Rotkreuz to Basel. You will own end-to-end address changes across Swiss-market artworks and manage related regulatory submissions where applicable.

The role requires cross-functional leadership, solid RA experience, and fluent German and English. The assignment spans 24 months with a focus on delivery, compliance, and audit-ready documentation.