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Project Manager, Regulatory Affairs-Preclinical

Aleon Pharma International, Inc.


Job Responsibilities

•Prepare and review documents for Investigational New Drug Applications (INDs), including nonclinical study reports, investigator’s brochures (IBs), clinical study protocols, clinical reports, summary documents, and other regulatory documents required for submission.

• Prepare and review special applications (including Orphan Drug Designations (ODDs), Fast Track Designations (FTDs), Breakthrough Therapy Designations (BTDs), and more).
• Prepare and review development safety update reports (DSURs).
• Provide nonclinical development strategies for IND-enabling studies.
• QC regulatory documents for compliance with FDA requirements, ICH requirements, and industry standards.
• Ensure consistency of clinical documents to maintain Aleon’s high-quality standards.
• Facilitate the finalization process of regulatory documents for submission.
• Manage project planning, operation, and reporting of assigned projects as needed.
• Effectively manage the communication with the sponsor and vendors as an IND project lead throughout the project.



• PhD/PharmD/Masters in a scientific discipline (toxicology, biological sciences, pharmaceutical sciences, etc.).
• Medical / Scientific writing experience or training preferred.
• We are willing to train exceptional candidates who can demonstrate quality and potential.

Skills and Requirements:

• Organized: Follows developed company goals and plans, stays very aware of all to-dos and events.
• Can-do attitude: Dares to try new methods, dares to reach out in an unfamiliar environment.
• Innovative: Seeks to implement improvements to make their role and Aleon more efficient.
• Time Management: Capability to plan carefully and meet project timelines.
• Hard working: Works diligently and effectively.
• Collaborative: Reaches out to peers and collaborates well with other functions.

If you feel that you are a good fit for this position, email your resume to or

Location: New Jersey


Post Date: 12/17/2021 10:44:34 AM
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