Demo

Regulatory Labelling Consultant

i-Pharm GxP
Billerica, MA Full Time
POSTED ON 2/19/2025
AVAILABLE BEFORE 5/16/2025

Regulatory Labeling Consultant – On-Site in North Billerica, MA

Initial Contract through December 31st, 2025

W2 Only | Competitive Hourly Rate

We are seeking a highly skilled Regulatory Labeling Consultant to join a leading pharmaceutical organisation in North Billerica, MA. This is a critical role focused on ensuring regulatory compliance and improving labeling processes for sterile injectables and medical devices.

Key Responsibilities :

  • Oversee and maintain regulatory labeling systems to ensure compliance with FDA, EMA, and related global standards.
  • Manage and implement label change requests (LCR) to support product lifecycle updates and regulatory submissions.
  • Collaborate with cross-functional teams, including regulatory, quality, and manufacturing, to ensure label updates meet both regulatory and internal requirements.
  • Identify and implement process improvements to enhance efficiency, compliance, and risk mitigation within labeling workflows.
  • Drive labeling projects from initiation to execution, ensuring timelines align with regulatory and product launch requirements.
  • Provide technical expertise and support for labeling issues, ensuring all label specifications adhere to global regulatory standards.

Qualifications :

  • 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, with specific expertise in sterile injectables.
  • Strong knowledge of cGMP, FDA, EMA, and USP guidelines.
  • Experience with label artwork changes, regulatory submissions, and quality systems.
  • Proven ability to manage multiple projects simultaneously and collaborate with cross-functional teams.
  • This is an excellent opportunity to contribute to high-impact projects with a global pharmaceutical leader. Apply today to learn more!

    Hamish Corson

    Senior Business Manager | USA | GxP Contract Division

  • 1 646 536 4736 (USA)
  • HCorson@i-pharmconsulting.com

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