Demo

Sterile Injectables Labeling Expert

i-Pharm GxP
North Billerica, MA Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 3/31/2025

About the Role

We are seeking an experienced Regulatory Labeling Consultant to join our team at i-Pharm GxP. As a key member of our regulatory affairs team, you will be responsible for ensuring that our labeling processes are compliant with relevant regulations and guidelines.

Responsibilities:

  • Maintain and update regulatory labeling systems to ensure accuracy and consistency.
  • Collaborate with cross-functional teams to identify and implement process improvements.
  • Manage label change requests and drive labeling projects from initiation to execution.
  • Provide technical expertise and support for labeling issues.

Requirements:

  • Bachelor's degree in Regulatory Affairs, Engineering, or a related field.
  • 3-5 years of experience in regulatory labeling within the pharmaceutical or medical device industry.
  • Strong knowledge of cGMP, FDA, EMA, and USP guidelines.
  • Experience with label artwork changes, regulatory submissions, and quality systems.

This is an exciting opportunity to join a dynamic team and contribute to the success of i-Pharm GxP.

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