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Regulatory Publishing Manager

Company: VirtualVocations
Location: Las Cruces
Posted on: March 12, 2025

Job Description:

A company is looking for a Manager/Sr. Manager, Regulatory Publishing & Operations.
Key Responsibilities

Lead US FDA and select EU submission projects in collaboration with Regulatory Affairs teams
Manage submission preparation, transmission, and archival, ensuring compliance with internal processes and regional standards
Provide subject matter expertise for submission documents and contribute to process improvement initiatives

Required Qualifications

Bachelor's degree in a life science or relevant discipline required
3+ years of in-depth regulatory operations experience in pharmaceutical and/or biotech product development
4+ years of pharmaceutical or biotech industry experience
Recent experience managing the creation and submission of regulatory documents accepted on technical grounds at first pass
Experience with Electronic Document Management Systems (Veeva RIM) and knowledge of ICH, FDA, and EMA submission guidelines

Keywords: VirtualVocations, Las Cruces , Regulatory Publishing Manager, Advertising , Las Cruces, New Mexico

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