Regulatory Affairs Lead — Basel Relocation & Swissmedic

Sandoz; Risch-Rotkreuz; On-site; CHF 140,000 - 180,000; Full time

Job summary

Sandoz is seeking a Regulatory Affairs Manager to lead the address-change workstream for the Rotkreuz to Basel relocation, overseeing Swissmedic submissions, artwork updates and cross-functional alignment. You will own the regulatory plan, manage document control, and ensure timely delivery with QA, Supply and packaging teams across Switzerland, while maintaining compliance and audit readiness.

This 24-month contract offers a dynamic environment in a leading biosimilar/generic medicines company

Qualifications

• Bachelor’s degree in biomedical, life or pharmaceutical sciences or equivalent.
• 3+ years in pharmaceutical Regulatory Affairs with lifecycle changes.
• Fluent German and English; French/Italian desirable.
• Experience managing Swissmedic submissions and packaging/artwork approvals.
• Ability to lead cross-functional regulatory projects with strong documentation control.

Responsibilities

• Own the address-change workstream for Basel relocation and Basel Swiss-market artworks.
• Define regulatory implementation plan, priorities and milestones with RA and relocation teams.
• Lead submissions to Swissmedic and follow-up with authorities as needed.
• Coordinate artwork workflows across QA, Supply and manufacturing for new address data.
• Manage regulatory data in databases and trackers with accurate reconciliation.
• Provide progress reports and drive risk mitigation for on-time delivery.

Skills

German language

English language

Regulatory project leadership

Swissmedic submissions

Regulatory databases

Artwork/document management systems

MS Office

Cross-functional collaboration

Education

Bachelor’s degree in biomedical, life or pharmaceutical sciences

Postgraduate qualification in regulatory affairs (desirable)

Tools

SAP

Regulatory databases

Artwork management systems

Job description

Sandoz is seeking a Regulatory Affairs Manager to lead the address-change workstream for the Rotkreuz to Basel relocation, overseeing Swissmedic submissions, artwork updates and cross-functional alignment. You will own the regulatory plan, manage document control, and ensure timely delivery with QA, Supply and packaging teams across Switzerland, while maintaining compliance and audit readiness.

This 24-month contract offers a dynamic environment in a leading biosimilar/generic medicines company