Principle Regulatory Systems Manager

DNA Life Sciences; Córdoba; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

An innovative consultancy is seeking a Principle Regulatory Systems Manager to drive digital transformation in the Life Sciences sector. This remote role requires expertise in Regulatory Operations and Information Management, with a focus on implementing advanced systems. You will take ownership of projects, ensuring exceptional quality and compliance while enhancing business processes. Your deep understanding of regulatory guidelines and exceptional communication skills will enable you to collaborate effectively across teams and with software vendors. Join a forward-thinking organization that values knowledge sharing and continuous improvement.

Formación

• 5-8+ years in the Pharmaceutical Industry focusing on Regulatory Operations.
• Practical experience with xEVMPD and IDMP guidelines.

Responsabilidades

• Lead projects ensuring customer expectations are met with high quality.
• Establish best practices and oversee data migration processes.

Conocimientos

Regulatory Operations

Regulatory Information Management

xEVMPD

IDMP

Data Migration Strategies

Communication Skills

Herramientas

RIM Systems

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.

Location : 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.

Reach out to if you have any questions regarding the role.