job title: Associate regulatory affairs (amneal pharma)

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.