Regulatory Affairs Specialist
The Regulatory Information Management System (RIMS) RA Specialist provides support for the global deployment and maintenance of RIMS. Ensure that RIMS activities for Regulatory Affairs (RA) are carried out according to established requirements and procedures. Contribute to additional RIMS projects as needed and works closely with RA Team members on RIMS activities.
Responsibilities
• Support the global regulatory information management (RIM) activities and support key regulatory Affairs (RA) systems and processes, including the global implementation of the Regulatory Information Management System (RIMS).
• Support RA change management and notifications in RIMS.
• Ensure all data related to regulatory submissions, registrations and agency correspondences are managed within the global system (RIMS) accurately and in accordance with approved procedures and work instructions.
• Maintain regulatory information in the RA systems for submissions, registrations and associated product data.
• Support data analysis, mapping and migration activities from legacy systems to RIMS
• Ensure data is available in a complete, accurate, and timely manner.
• Monitor and maintain a high quality data in RA systems.
• Maintain awareness of regulatory requirements and procedures and how changes may impact maintenance of RA data within RIMS.
• Assist in global implementing system upgrades and other improvements, including system testing and user training as needed.
• Provide RIMS support to RA team members.
• Prioritize issues and escalate technical problems to IT.
• Hold periodic meetings to share tips and maintain regular communication with RA team members and end-users.
• Support publishing activities for US and EU submissions
• Support the generation of queries, metrics and reports
• Maintain compliance with RA procedures and Work Instructions
• Work with cross-functional teams (RA, IT and ICS)
Education and Experience
• Bachelor of Science in a relevant scientific or technical field.
• Preferred regulatory affairs experience in medical devices/pharmaceutical industry.
• Working background with either customized or commercial RIM software systems.
• Solid understanding of the principles of RIMS management and business process workflow