Regulatory Business Analyst

Mandatory Skills

Pharma Regulatory systems / ENNOV RIM

• Configure and support Ennov RIM modules including submissions, registrations, and product lifecycle management
• Strong understanding and experience with the Ennov RIM system's capabilities and the underlying Extended Data Objects EDO technology.
• Participate in Ennov RIM implementation and migration projects, ensuring system alignment with regulatory processes Provide expert level knowledge of the Ennov RIM system's features, functionality, and configurations for managing regulatory data and processes. Ensure compliance with GxP and support Computer System Validation CSV activities and related documentation
• Act as liaison between business users and technical teams, providing clear communication and issue resolution Map existing regulatory workflows, propose improvements, and support process optimization initiatives within RIM
• Excellent communication skills for interacting with clients and internal teams, and the ability to translate technical information into understandable terms.
• Support the implementation of Ennov RIM solutions, including user training and system configuration to align with client needs. Collaborate with clients to understand their regulatory challenges and help them streamline end to end RIM activities, from product registration to submission management.