Regulatory Affairs Specialist - Biosimilars (Switzerland)

C115 (FCRS = CH115) Sandoz Pharmaceuticals AG; Rotkreuz; Sur place; CHF 70 000 - 95 000; Plein temps

Résumé du poste

Sandoz is seeking a Regulatory Affairs professional to support local regulatory activities at Rotkreuz, Switzerland, with relocation to Basel from 01 January 2028. The role involves ensuring adherence to procedures, assisting audits, and maintaining registration files across biosimilar and generic medicines landscapes.

Ideal candidates have a relevant degree, 1+ year experience, and strong German/English language skills; French/Italian are desirable. MS Office and SAP proficiency is expected.

Qualifications

• Bachelor degree or equivalent in related field.
• 1+ year of relevant work experience preferred.
• Fluent German and English; French/Italian desirable.
• Experience in a highly regulated environment.
• Strong planning, organization and attention to detail.
• Strong written communication skills.
• Data management and IT skills (MS Office, SAP).

Responsabilités

• Ensure adherence to local procedures and maintain records.
• Support regulatory activities during audits and health authority inspections.
• Assist in creation and translation of official product information including SmPCs and labeling.
• Maintain registration files and regulatory databases.
• Support administrative activities and KPI reporting.
• Coordinate regulatory tasks related to RMP/RMA and DHPC.
• Support RA projects and cross-functional regulatory initiatives.

Connaissances

German (fluent)

English (fluent)

French (desirable)

Italian (desirable)

Formation

Bachelor in Bio-Medical / Life Sciences / Pharmaceutical sciences or admin degree

Outils

MS Office

SAP

Description du poste

Sandoz is seeking a Regulatory Affairs professional to support local regulatory activities at Rotkreuz, Switzerland, with relocation to Basel from 01 January 2028. The role involves ensuring adherence to procedures, assisting audits, and maintaining registration files across biosimilar and generic medicines landscapes.

Ideal candidates have a relevant degree, 1+ year experience, and strong German/English language skills; French/Italian are desirable. MS Office and SAP proficiency is expected.