Regulatory Operations Associate II

Support to CPDS (Chemical and Pharmaceutical Development & Supply) team (1 FTE):

• Training management (Curricula maintenance and updating, daily follow-up for trainings, Instructor Lead Course (ILC) creation, new users/existing users training management in Compliance wire (CW), etc.
• Electronic Lab Notebook (ELN) support activities (spreadsheet validation, periodic review of users, user groups, templates etc.
• Tru‐ vault Docs handling (controlled prints, uploading & routing of documents for review/approvals, Projects, SOPs, work instructions (WI), forms etc.
• Activities related to upgradation of existing systems/software (e.g. Windows 10 migration, Project Olympus, RIMS 5 etc.)
• Responsible for computerized System Validation
• Scientific support systems like Deskman, FR5, Open lab, Empower as well as compliance and few DI aspects etc.

Learn more about our EEO & Accommodations request here.