Regulatory Affairs Associate I

Role Summary

Regulatory Affairs Associate I, Regulatory Submissions Management, is responsible for publishing and dispatch of basic and complex lifecycle management eCTD submissions and ensuring technical validation. They have a working knowledge of internal/external publishing standards, electronic publishing/viewing software tools and document management systems. Independently performs document level publishing activities, troubleshoots document issues and performs quality control checks for submission-ready documents.

Responsibilities

• Publish and dispatch major and complex routine/lifecycle management eCTD submission projects
• Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission-ready documents
• Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions
• Participate in Global Regulatory Affairs project teams
• Maintain working knowledge of internal and external publishing standards
• Follows Teva Safety, Health, and Environmental policies and procedures

Qualifications

• Required: 0-2 years in Regulatory Operations/Regulatory Affairs
• Preferred: Experience as a publisher for regulatory applications

Skills

• Experience with Liquent InSight suite, Microsoft Office suite, Adobe, Documentum, and eCTD technology
• Basic understanding of IT infrastructure
• Understanding of the drug development process. Knowledge of generics and branded product development a plus
• Working knowledge of industry legislation and best practices
• Strong knowledge of regulations/guidelines governing regulatory submissions (eCTD, NeeS, paper)

Education

• Required: Bachelor’s Degree
• Preferred: Bachelor’s Degree in Life Sciences or Information Technology