Regulatory Affairs Associate

About This Role

This role is responsible for the publishing and dispatch of basic and complex lifecycle management eCTD submissions, ensuring technical validation. The associate will independently perform document level publishing activities, troubleshoot issues, and perform 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

Requirements

• Bachelor’s Degree
• 0-2 years in Regulatory Operations/Regulatory Affairs
• Working knowledge of industry legislation and best practices
• Strong knowledge of regulations/guidelines governing regulatory submissions (eCTD, NeeS, paper)

Qualifications

• Bachelor’s Degree in Life Sciences or Information Technology
• 0-2 years in Regulatory Operations/Regulatory Affairs

Nice to Have

• Experience as a publisher for regulatory applications
• 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

Skills

* Required skills

Benefits