Principle Regulatory Systems Manager

DNA Life Sciences; Salamanca; A distancia; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A leading consultancy in the Life Sciences sector is seeking a Principle Regulatory Systems Manager to drive digital transformation. This remote role requires expertise in regulatory operations and information management, focusing on enhancing client compliance and data governance. The candidate will lead projects, collaborate with teams, and implement best practices to optimize efficiency and meet regulatory standards.

Formación

• 5-8+ years of experience in the Pharmaceutical Industry.
• Practical experience with xEVMPD and IDMP.

Responsabilidades

• Lead projects to ensure customer expectations are met with quality.
• Establish best practices for client value delivery.

Conocimientos

Regulatory Operations

Regulatory Information Management

Data Migration

Communication

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.

J-18808-Ljbffr