Scientific Affairs Specialist - Germany

Stellenbeschreibung:

Overview

In this role you will serve as the local Scientific Affairs expert for Central Europe, ensuring product quality, patient safety, and regulatory compliance. You will bridge Global Scientific Affairs with local commercial teams and act as the primary contact for inquiries from pharmacies, healthcare professionals, authorities, and consumers. You will manage compliant product launches, lead local pharmacovigilance activities, and support marketing and training efforts to drive cross-market safety and compliance. This position combines science, compliance, and commercial execution in a fast-growing, M&A-driven environment. You will work across a diverse, international team and contribute to theK

Leistungen / Benefits
  • Flexible schedule
  • Hybrid work model
  • Impactful projects
  • Positive, international work environment
  • Start-up spirit within a large organization
  • Diversity and inclusion
Verantwortungsbereiche
  • Act as local Scientific Affairs expert for Central Europe
  • Link Global Scientific Affairs with local commercial teams to ensure safety and regulatory compliance
  • Be first point of contact for inquiries and complaints from pharmacies, HCPs, authorities, and consumers
  • Manage compliant product launches including regulatory submissions and labeling
  • Lead local drug shortage reporting in collaboration with Global QA
  • Oversee local pharmacovigilance activities and act as Local PV Contact
  • Monitor safety reporting and literature per GVP; review marketing materials for compliance
  • Support commercial teams as compliance partner in a fast-paced setting
  • Contribute to local SOP updates and Global QMS implementation
  • Deliver PV and compliance training to affiliates, partners, and distributors
  • Engage in local training under Global Scientific Affairs guidance and QMS activation
  • Ensure local reconciliation with global and regional teams for product safety surveillance
  • Ensure SOPs compliance with local regulations and Global SOPs coverage
  • Manage day-to-day operations with 3PLs, customers, and distributors including audits and agreements
Zentrale Anforderungen
  • University degree in Medicine, Pharmacy, Veterinary medicine, Biology, Chemistry, or a comparable scientific discipline
  • 4+ years’ experience in Regulatory Affairs, Quality, or Scientific Affairs within healthcare
  • Experience with pharmacovigilance processes, safety case reporting, and GVP requirements
  • Solid understanding of product compliance, lifecycle management, and health authority interactions
  • Experience reviewing marketing materials and promotional claims for compliance
  • Experience with local submissions and dossier handling
  • Experience with authority-facing pharmacovigilance communication
  • Experience delivering pharmacovigilance or compliance training
  • Comfortable working cross-functionally in an international, fast-moving organization
  • Fluent in English and German
  • Eligible to work in Germany
  • Cross-functional collaboration
  • Attention to detail
  • Strong communication
  • Regulatory affairs
  • Pharmacovigilance (PV)
  • GVP compliance
NOTE / HINWEIS:
EnglishEN: Please refer to Fuchsjobs for the source of your application
DeutschDE: Bitte erwähne Fuchsjobs, als Quelle Deiner Bewerbung

Stelleninformationen

  • Veröffentlichungsdatum:

    14 Sep 2026
  • Standort:

    Düsseldorf
  • Typ:

    Vollzeit
  • Arbeitsmodell:

    Vor Ort
  • Kategorie:

  • Erfahrung:

    2+ years
  • Arbeitsverhältnis:

    Angestellt

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