Senior Manager, Regulatory Labeling

Company: VirtualVocations
Location: Provo
Posted on: April 6, 2025

Job Description:

A company is looking for a Senior Manager, Global Regulatory Device Labeling Strategy Lead.
Key Responsibilities

Provide regulatory expertise and strategic guidance for the development and maintenance of labeling documents in compliance with US and EU standards
Lead cross-functional teams to align labeling strategies and content for various products, including combination and standalone medical devices
Manage the lifecycle of labeling components and ensure compliance with internal procedures and Health Authority requirements

Required Qualifications

4-7 years of experience in the biopharmaceutical industry, with up to 3 years in a global labeling role preferred
Bachelor's or Master's degree required; advanced scientific or health sciences degree preferred
Detailed understanding of pharmaceutical drug and device development, specifically EU and US labeling regulations
Expertise in developing and maintaining Company Core Data Sheet, USPI, and EU SmPC
Proficiency in Electronic Document Management Systems and End-to-End Labeling Tracking Systems

Keywords: VirtualVocations, Provo , Senior Manager, Regulatory Labeling, Executive , Provo, Utah