Associate, Regulatory Affairs
Amneal Pharmaceuticals
Date: 3 weeks ago
City: Ahmedabad, Gujarat
Contract type: Full time
Job Description
Job Description: Document Level Publishing (DLP) Specialist – SIE RA
Key Responsibilities
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
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.
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
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