Senior Manager, Device Labeling - Port Saint Lucie Florida

Company: VirtualVocations
Location: Port Saint Lucie, Florida
Posted On: 01/18/2025

A company is looking for a Senior Manager, Global Labeling Devices.



Key Responsibilities

Lead cross-functional teams to develop and align labeling strategies and content for Instruction for Use (IFU) documents
Author and manage labeling documents, ensuring compliance with regulatory requirements and timely submissions
Conduct precedent searches and analyze competitor labeling to develop competitive strategies for product labels


Required Qualifications

BSc degree preferred; advanced scientific degree (MSc, PhD, or PharmD) preferred
6+ years of pharmaceutical industry experience, including 4 years of labeling or regulatory experience
Knowledge of US and EU product labeling regulatory requirements and guidelines
Basic understanding of scientific principles and regulatory/quality systems relevant to drug development
Ability to develop regulatory strategies based on requirements and competitive landscape More...

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