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Regulatory Affairs Labeling Specialist

Talent Group New York ,NY
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

***This is a REMOTE work from home opportunity*** 

 

***This candidate must have Labeling Strategy AND EMA/FDA experience***

Needs: 10+ years of labeling, has done strategy work, experience working with Health Authorities, Pharmaceutical experience, experience managing a global team, client interface experience preferably with a vendor

Support pre and post approval labeling strategy. Formulate a  strategy for compliant (and perhaps innovative) labeling based on evolving product development programs. Support the compliance with internal SOPs, policies and health authority regulations, including compilation and submission of any required documents to regulatory agencies. 

·        12 plus years of experience Regulatory Affairs/Labeling

·        Knowledge of the principles and concepts of labeling and underlying SOP's

·        Must be able to construct a company response (MAH response) for health authority questions

·        Monitor Reference labels for updates and ability to communicate with concerned affiliates directly using company communication/collaboration tools

·        Up to date with labeling guidelines and regulations

 

Company Description
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