Associate, Regulatory Affairs

🏢 Job Title: Associate, Regulatory Affairs

📍 Location: Ahmedabad, Gujarat, India
🏢 Company: Amneal Pharmaceuticals


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🧬 About the Company:

Amneal Pharmaceuticals is a rapidly growing global pharmaceutical company committed to making healthy possible. With a diversified portfolio of generic and specialty medicines, Amneal is focused on delivering affordable, high-quality solutions that meet patient and customer needs. The company fosters an inclusive work environment and values innovation, collaboration, and continuous improvement.


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


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🎯 Key Responsibilities:

Collaborate with the Submission Level Publisher to ensure accurate and timely document processing.

Handle daily PDF processing tasks based on project requirements and workload.

Ensure strict adherence to submission timelines and regulatory deadlines.

Troubleshoot issues using ISI Toolbox to resolve document processing challenges.

Conduct thorough Quality Control (QC) checks on PDF files including:

Bookmarking

Hyperlinking

Table of Contents (TOC) accuracy


Apply corrections in PDF files based on QC feedback or review comments.

Escalate critical issues to the Submission Specialist, especially those related to ISI Toolbox.

Follow internal file naming conventions as per Amneal standards.

Actively support team efforts in eCTD submissions and other publishing tasks.



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🧑‍💻 About the Role:

This position plays a critical part in the Regulatory Affairs team, focusing on the accuracy and quality of submission-ready documents. It demands precision, technical know-how in regulatory tools like ISI Toolbox, and a team-oriented mindset.


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🌍 Diversity & Inclusion at Amneal:

Amneal is an equal opportunity employer, committed to creating a diverse and inclusive environment. The company does not discriminate on the basis of caste, religion, gender, disability, or any legally protected status.


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📝 How to Apply:

To know more about job details & to apply, visit here:


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⚠️ Disclaimer:

This post is for informational purposes only and is not affiliated directly with the hiring organization. Candidates are advised to refer to the official company website or contact the employer directly for application details. No registration fee is involved.

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