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FRFresenius Medical Care (Schweiz) AG

vor 11 Tagen

Cluster Expert Pre and Pos Market Drugs and Supply Chain Quality(m/w/x)

Oberdorf (NW)

Vollzeitmit HomeofficeJunior

Nejo KI-Zusammenfassung

Regulatory and quality lead for cluster, managing registrations and serving as primary contact for authorities and stakeholders. Advanced training in Regulatory Affairs and pharmacovigilance required. Hybrid work, career planning opportunities.

Anforderungen

Minimum BA university degree in Pharmacy, Pharmaceutical Sciences, Biochemistry, Biology, Bioengineering, Health Sciences, or similar
Advanced training in Regulatory Affairs of medicinal products
Advanced training in pharmacovigilance
At least 2-4 years experience in similar position
Minimum 2 years experience in regulatory affairs in MedTech/Pharma industry
Minimum 2 years experience in regulatory submissions, filings, and compliance
Minimum 2 years experience in MedTech industry
Extensive experience processing documentation and controls
2-3 years professional experience in GDP-related activities
At least 1 year experience in pharmacovigilance and knowledge of local regulations
Good knowledge in applicable legal and regulatory laws
Good knowledge of ISO 9001, ISO 13485, GxP regulations
Proficiency in Regulatory Software: Familiarity with regulatory management tools, document management systems, and databases
High proficiency in MS Office applications, SharePoint, MS-Teams, with ability to adapt to new technologies
High language proficiency in English and native language (written and spoken)
Other languages are an asset

Aufgaben

Act as regulatory and quality lead for the cluster
Serve as primary contact for regulatory authorities
Serve as primary contact for internal stakeholders
Manage regulatory affairs
Manage registrations
Manage renewals
Manage variations
Manage product information updates
Oversee local pharmacovigilance activities
Ensure compliance with global PV requirements
Ensure GDP compliance throughout supply chain
Oversee distributors
Oversee logistics partners
Monitor regulatory changes
Provide regulatory intelligence
Support audits
Support inspections
Drive governance
Drive GxP training
Drive continuous improvement initiatives

Berufserfahrung

1 Jahr

Ausbildung

Abgeschlossene BerufsausbildungODER
Bachelor-Abschluss

Sprachen

Englisch – fließend
native – fließend

Tools & Technologien

Regulatory Software
MS Office applications
SharePoint
MS-Teams

Benefits

Karriere- und Weiterentwicklung

Career planning opportunities

Weiterbildungsangebote

Professional development

Flexibles Arbeiten

Hybrid work

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FRFresenius Medical Care (Schweiz) AG

vor 11 Tagen