Principle Regulatory Systems Manager

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

DNA Life Sciences is collaborating with a specialized consultancy dedicated to delivering innovative solutions to drive digital transformation within the Life Sciences and Pharmaceutical sectors. They support organizations in enhancing regulatory operations, data management, and compliance processes through the implementation of 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.

Position: Principle Regulatory Systems Manager - Remote

• Remote role, but candidates must be based in:

Austria, Spain, Croatia, Germany, Poland, or the Netherlands

Required Experience:

• 5-8+ years of experience in the Pharmaceutical Industry, focusing on Regulatory Operations and Regulatory Information Management.
• Practical experience with xEVMPD and IDMP, including thorough knowledge of relevant guidelines such as the EU IDMP Implementation Guide.
• Proven track record in implementing and operating RIM systems, along with developing and executing data migration strategies.
• Deep understanding of regulatory processes and data, enabling effective collaboration across various functional areas within the pharmaceutical value chain.
• Excellent communication skills and the ability to work effectively as part of a team.

Responsibilities:

• Lead projects and teams to ensure customer expectations are met with high quality.
• Establish and implement best practices for delivering value, including conducting workshops, gathering requirements, selecting vendors, and overseeing data migration.
• Act as a liaison between the business and software vendors to ensure effective communication and alignment.
• Optimize business processes to meet internal and external requirements, enhancing efficiency and compliance.
• Promote organizational values and methodologies, fostering a unified approach.
• Encourage knowledge sharing and continuously seek opportunities to improve team performance.

For any questions regarding the role, please reach out.