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Regulatory Publishing Manager
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
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