Teva Regulatory Affairs Associate III 

United States, New Jersey 

249090115

The Regulatory Affairs Associate III, (Regulatory Submissions Management,) is responsible for the publishing and dispatch of major and complex lifecycle management eCTD submissions and ensuring technical validation. They have proficient 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. Trains junior staff on processes, standards and tools and delegates publishing tasks.

• 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.
• Lead and participate in Global Regulatory Affairs project teams
• Train junior staff on processes and tools
  

Required:

• Bachelor's Degree preferably in Life Sciences or Information Technology
• A minimum of 4 years of Regulatory Operations/Regulatory Affairs. (Experience as a publisher for regulatory applications preferred.)

Preferred:

• Experience with eCTD technologies, Microsoft Office, Adobe Acrobat, and Documentum. Liquent Insight a plus.
• Basic understanding of IT infrastructure
• Understanding of the drug development process. Knowledge of generics and branded product development a plus.
• Proficient knowledge of regulations/guidelines governing regulatory submissions.
• Working knowledge of industry legislation and best practices.
  

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