The Regulatory Information Management System (RIMS) associate 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.
Principal Duties and ResponsibilitiesResponsibilities
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)
Expected Areas of CompetenceSkills and Competencies
Attention to detail and capable of working in an organized and consistent manner.
Solid understanding of the principles of RIMS management and business process workflow
Strong analytical and problem solving skills
Ability to manage multiple projects simultaneously with high degree of accuracy and attention to detail
Work independently and collaboratively to accomplish responsibilities, goals and projects
Provide excellent customer service to both internal and external customers
Exhibit excellent written and oral communication skills
Education/Experience RequirementsBachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field preferred
0-2 years of regulatory affairs experience preferred
Limited regulatory submission preparation experience a plus
Travel RequirementsUp to 10%