Associate, Regulatory Affairs

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.
  

Qualifications

Key Skills

Document Publishing & Processing

• Proficiency in PDF editing and formatting (e.g., bookmarking, hyperlinking, TOC creation).
• Experience with ISI Toolbox or similar regulatory publishing tools.
  

Regulatory Submission Knowledge

• Understanding of eCTD structure, regulatory submission standards, and timelines.
• Familiarity with regulatory authority requirements (e.g., FDA, EMA).
  

Quality Control & Attention to Detail

• Strong focus on accuracy and consistency in document formatting.
• Ability to perform QC checks and implement corrections efficiently.
  

Technical Troubleshooting

• Ability to identify and resolve technical issues in document processing tools.
• Escalation and communication of issues to relevant stakeholders.
  

Time Management & Prioritization

• Managing daily workloads while meeting tight submission deadlines.
  

Collaboration & Communication

• Working closely with Submission Level Publishers and team members.
• Providing peer support and participating in group activities.
  

File Management

• Adherence to internal file naming conventions and document traceability standards.
  

🎓 Qualifications

Education

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
  

Experience

• 1–3 years in regulatory publishing, document management, or regulatory operations.
• Experience with eCTD submissions and document formatting tools.
  

Certifications (Optional But Beneficial)

• Regulatory Affairs Certification (RAC)
• Training in eCTD publishing tools or document management systems
  

About Us