Biosimilars Regulatory Affairs Manager

206030 Fresenius Kabi SwissBioSim GmbH; Eysins; Vor Ort; CHF 114.000 - 155.000; Vollzeit

Zusammenfassung

Fresenius Kabi USA is seeking an experienced Regulatory Affairs Manager to support development and execution of global regulatory strategies for biosimilar products. You will coordinate submission activities, dossier preparation, and lifecycle management under the guidance of the Regulatory Affairs Lead Director across cross-functional teams and Health Authority interactions.

The role requires extensive experience in regulatory submissions and a strong understanding of biosimilar product

Qualifikationen

• Bachelor's degree in life science or related field.
• 6–8 years of regulatory affairs experience, biologics/biosimilars preferred.
• Experience with international/regional submissions (US/EU).

Aufgaben

• Manage lifecycle and post-approval activities for biosimilar products.
• Support global regulatory strategies and integrated plans with RAL Director.
• Coordinate preparation and delivery of submission documents to health authorities.
• Lead timelines, risks, decisions, and actions across cross-functional teams.
• Provide regulatory guidance for affiliates on local submissions and constraints.
• Assist in meetings with health authorities and document follow-up actions.

Kenntnisse

Regulatory strategy

Cross-functional teamwork

Regulatory submissions

Communication skills

Ausbildung

Bachelor's degree in life science

Jobbeschreibung

Fresenius Kabi USA is seeking an experienced Regulatory Affairs Manager to support development and execution of global regulatory strategies for biosimilar products. You will coordinate submission activities, dossier preparation, and lifecycle management under the guidance of the Regulatory Affairs Lead Director across cross-functional teams and Health Authority interactions.

The role requires extensive experience in regulatory submissions and a strong understanding of biosimilar product