Principle Regulatory Systems Manager

buscojobs España; Madrid; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

Ein innovatives Unternehmen im Bereich Life Sciences sucht einen Principle Regulatory Systems Manager, der die digitale Transformation in der Pharmaindustrie vorantreibt. In dieser spannenden Rolle sind Sie verantwortlich für die Implementierung fortschrittlicher Systeme und Technologien zur Optimierung regulatorischer Abläufe und Datenmanagement. Sie arbeiten eng mit verschiedenen Fachbereichen zusammen, um sicherzustellen, dass regulatorische Anforderungen effizient erfüllt werden. Dies ist eine großartige Gelegenheit, Ihre Expertise in einem dynamischen Umfeld einzubringen und zur Verbesserung der Compliance-Prozesse beizutragen. Wenn Sie leidenschaftlich an der Pharmaindustrie interessiert sind und einen bedeutenden Einfluss ausüben möchten, bewerben Sie sich jetzt!

Formación

• 5-8+ Jahre Erfahrung in der Pharmaindustrie mit Schwerpunkt auf regulatorischen Abläufen.
• Praktische Erfahrung mit xEVMPD und IDMP sowie umfassende Kenntnisse relevanter Richtlinien.

Responsabilidades

• Leiten von Projekten und Sicherstellen der Erfüllung der Kundenanforderungen mit hoher Qualität.
• Implementierung von Best Practices zur Wertschöpfung für Kunden und Überwachung von Datenmigrationsprozessen.

Conocimientos

Regulatory Operations

Regulatory Information Management (RIM)

Data Migration Strategies

Communication Skills

Descripción del empleo

Principle Regulatory Systems Manager (xEVMPD and IDMP, RIM Systems implementation) - Pharmaceutical And Biotech

DNA Life Sciences is working with a specialized consultancy focused on delivering innovative solutions to drive digital transformation within the Life Sciences and Pharmaceutical sectors. They support organizations in enhancing their regulatory operations, data management, and compliance processes by implementing advanced systems and technologies. Their expertise includes streamlining regulatory information management (RIM), master data management (MDM), and data governance to ensure efficient regulatory submissions and compliance.

Principle Regulatory Systems Manager - Remote

• Remote role, but must be based in either: Austria, Spain, Croatia, Germany, Poland or Netherlands.

Required Experience:

• 5-8+ years of experience in the Pharmaceutical Industry, specializing in Regulatory Operations and Regulatory Information Management.
• Practical experience with xEVMPD and IDMP, along with comprehensive knowledge of relevant guidelines, such as the EU IDMP Implementation Guide.
• Proven experience in implementing and operating RIM systems, as well as developing and executing data migration strategies.
• A deep understanding of regulatory processes and data, allowing you to effectively collaborate across various functional areas within the pharmaceutical value chain.
• Excellent communication skills and the ability to work effectively as a collaborative team player.

Responsibilities:

• Take ownership of one or more projects, leading a team to ensure customer expectations are consistently met with exceptional quality.
• Establish and implement best practices for delivering value to clients, including conducting workshops, gathering requirements, selecting vendors, and overseeing data migration processes.
• Serve as a liaison between the business and software vendors, ensuring effective communication and alignment of objectives.
• Enhance business processes to meet both internal and external requirements, optimizing efficiency and compliance.
• Promote organizational values and methodologies, fostering a unified approach to work.
• Cultivate a culture of knowledge sharing, continuously identifying opportunities to improve team performance.