Regulatory Affairs Systems and Data Manager

Role Overview

The Regulatory Affairs Systems and Data Manager will be accountable for the strategy and management of all systems and data within the regulatory affairs function. This includes the strategy and oversight of the regulatory information management system (RIM) and oversight of the regulatory systems support group and regulatory submission management and publishing teams. The role will also be responsible for regulatory data management and management of training and SOPs for regulatory.

What You Will Do

The Manager will be responsible for the ongoing strategy of the regulatory information management system, overseeing the implementation, maintenance, and optimization of Veeva RIM, and identifying opportunities to enhance RIM capabilities to streamline regulatory processes. They will also develop reporting mechanisms to ensure senior management has oversight of compliance and risks, and conduct audits and assessments to ensure regulatory data compliance.

Why It Might Be a Fit

The ideal candidate will have proven experience working in the pharmaceutical industry in a regulatory/regulatory operations function, proficiency in using Veeva Vault RIM, and understanding of global regulatory requirements and compliance standards.

Requirements

• Proven experience working in the pharmaceutical industry in a regulatory/regulatory operations function
• Proficiency in using Veeva Vault RIM
• Understanding of global regulatory requirements and compliance standards
• Excellent written and verbal communication skills
• Ability to work in a fast-paced, dynamic environment

Benefits

• Flexible benefits package
• Opportunities for learning & development through our varied programme
• Collaborative, inclusive work environment