Regulatory Specialist: Post‑Marketing & Data Remediation

Flexsis; Basel-Stadt; On-site; CHF 90,000 - 130,000; Full time

Job summary

Flexsis is seeking a Regulatory Specialist (m/f/d) based in Basel, Switzerland for a 12‑month contract with extension potential. The role focuses on commercial products, post‑marketing activities and data remediation, supporting global regulatory submissions and lifecycle management.

You will work with global technical teams to ensure compliant documentation, lead legacy data clean‑up and improve data quality using Veeva RIM, while coordinating risk assessments and change controls across

Qualifications

• Bachelor's degree or higher in a scientific, pharmaceutical or technical field.
• 3–4 years of experience in CMC Regulatory or Technical Regulatory affairs.
• Experience supporting commercial products and post-approval activities.
• Proficiency with change controls and regulatory deviations.
• Fluent English, written and spoken (C1).

Responsibilities

• Manage global CMC regulatory activities for commercial products.
• Support post-approval submissions and lifecycle management.
• Assess regulatory impact of changes and manage change controls.
• Review and remediate legacy regulatory data with documentation.
• Maintain regulatory information in Veeva RIM and related systems.
• Collaborate with international teams and external partners.

Skills

English (C1)

Analytical skills

Problem solving

Independent work

Education

Bachelor's degree or higher in a scientific field

Tools

Veeva RIM

Regulatory systems

Job description

Flexsis is seeking a Regulatory Specialist (m/f/d) based in Basel, Switzerland for a 12‑month contract with extension potential. The role focuses on commercial products, post‑marketing activities and data remediation, supporting global regulatory submissions and lifecycle management.

You will work with global technical teams to ensure compliant documentation, lead legacy data clean‑up and improve data quality using Veeva RIM, while coordinating risk assessments and change controls across