Strategic Direction: Design and implement European regulatory pathways that seamlessly align with worldwide clinical development roadmaps.Health Authority Interface: Act as the primary regional liaison for the European Medicines Agency (EMA) and coordinate communications with various national competent authorities across Europe.Agency Meetings: Direct the compilation, preparation, and execution of briefing documents for Scientific Advice procedures and other critical regulatory negotiations.Submission Management: Oversee complex European filing processes, including clinical trial applications, pediatric plans, orphan drug designations, initial marketing authorizations, and continuous lifecycle variations.Labeling & Compliance: Ensure regional labeling requirements are met and remain strictly consistent with central core product data sheets.Cross-Functional Leadership: Provide authoritative regulatory guidance to internal governance committees, global project groups, and due diligence activities for business development.Global Alignment: Drive international regulatory roadmaps, orchestrate worldwide submission planning, and guide regional sub-teams and affiliates to ensure successful local execution.Regulatory Intelligence: Monitor the evolving regulatory landscape to evaluate the strategic impact of new guidelines on the portfolio.Your ProfileEducation: Advanced university degree (Master's level or equivalent) in Life Sciences or a related scientific discipline.Industry Experience: Extensive senior-level background (8+ years) in Regulatory Affairs within the pharmaceutical or biotechnology sector.Regulatory Mastery: In-depth knowledge of European, ICH, and international regulatory frameworks.Agency Track Record: Proven history of direct interaction and successful collaboration with the EMA and European national competent authorities.Development Knowledge: Profound understanding of all phases of clinical drug development and post-approval lifecycle management.Leadership & Communication: Exceptional project management capabilities paired with strong stakeholder communication skills.Languages: Full professional fluency in English, both written and spoken. #J-18808-Ljbffr
Associate Director Regulatory Affairs (m/f/d) in Basel Arbeitgeber: Skilled Recruitment Solutions GmbH
Als Area Sales Manager Pharma (m/w/d) in unserem Unternehmen profitieren Sie von einer dynamischen und unterstützenden Arbeitsumgebung, die auf Teamarbeit und Innovation setzt. Wir bieten Ihnen nicht nur attraktive Vergütungspakete und flexible Arbeitszeiten, sondern auch umfangreiche Weiterbildungsmöglichkeiten, um Ihre Karriere im pharmazeutischen Bereich voranzutreiben. Unsere Unternehmenskultur fördert den Austausch mit Experten und ermöglicht Ihnen, aktiv an der Verbesserung der Patientenversorgung mitzuwirken.
Kontaktdaten:
Skilled Recruitment Solutions GmbH Recruiting-Team
