Associate, Regulatory Affairs

Job Description: Document Level Publishing (DLP) Specialist – SIE RA

Key Responsibilities:

• Collaborate closely with the Submission Level Publisher to ensure timely and accurate document processing.
• Perform daily PDF processing tasks as per assigned workload and project requirements.
• Adhere strictly to submission timelines and regulatory deadlines.
• Conduct troubleshooting using ISI Toolbox, resolving technical issues efficiently to avoid delays.
• Execute quality control (QC) checks of PDF files, focusing on:
  • Bookmarking
  • Hyperlinking
  • Table of Contents (TOC) accuracy
• Implement corrections in processed PDF files based on QC comments or review feedback.
• Escalate and communicate any processing issues to the Submission Specialist, particularly those involving ISI Toolbox.
• Ensure all files follow Amneal's internal file naming conventions for consistency and traceability.
• Actively participate in group activities and provide peer support within the team for eCTD submissions and related publishing tasks.