Regulatory Affairs Lead – Basel Relocation & Artworks (Temp)

Sandoz; Rotkreuz; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Sandoz is seeking a Regulatory Affairs Manager (d/f/m) for a 24-month temporary contract based in Rotkreuz, relocating to Basel. You will own the address-change workstream for the Swiss market, manage regulatory updates, and coordinate Swissmedic submissions where applicable, aligning with local RA governance.

The role requires cross-functional leadership across RA, QA, Supply, and artwork teams. You will drive risk mitigation, ensure compliant documentation, and deliver timely, inspection-ready

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

• Own the regulatory address-change workstream from the Basel relocation, ensuring timely, accurate updates across Swiss-market artworks and product information.
• Lead regulatory reviews of packaging texts and language versions; manage Swissmedic submissions where applicable and coordinate responses.
• Coordinate cross-functional teams (RA, QA, Supply, artwork) and maintain a consolidated project tracker with milestones and risks.
• Ensure archiving of regulatory documents, track progress, and communicate decisions to stakeholders.

Kenntnisse

Regulatory affairs

German language

English language

Cross-functional leadership

Documentation management

Swissmedic submissions

Ausbildung

Bachelor's degree in biomedical or pharmaceutical sciences

Tools

SAP

Jobbeschreibung

Sandoz is seeking a Regulatory Affairs Manager (d/f/m) for a 24-month temporary contract based in Rotkreuz, relocating to Basel. You will own the address-change workstream for the Swiss market, manage regulatory updates, and coordinate Swissmedic submissions where applicable, aligning with local RA governance.

The role requires cross-functional leadership across RA, QA, Supply, and artwork teams. You will drive risk mitigation, ensure compliant documentation, and deliver timely, inspection-ready