Demo

Director, Labeling Operations

Proclinical
Boston, MA Full Time
POSTED ON 2/27/2025
AVAILABLE BEFORE 5/20/2025

Director of Labeling Operations - Permanent - Boston, MA

Proclinical is seeking a Director of Labeling Operations for an exciting opportunity in a fast-growing biotech environment.

Primary Responsibilities :

This position focuses on leading labeling operations and driving key regulatory initiatives as the company expands its pipeline. If you are looking for a high-impact position in a dynamic and forward-thinking setting, this could be the perfect fit for you.

Skills & Requirements :

  • Expertise in developing and implementing labeling processes.
  • Experience in managing Health Authority interactions.
  • Strong ability to lead the development of regulatory response documents.
  • Knowledge of global labeling regulations and compliance standards.
  • Excellent cross-functional collaboration skills.

Th e Director of Labelling Operations' responsibilities will be :

  • Develop and implement global labeling operations processes, including SOPs and workflows.
  • Oversee interactions with Health Authorities concerning labeling artwork, compliance, and regulatory commitments.
  • Lead the creation of response documents for regulatory agencies.
  • Ensure adherence to global labeling regulations and internal standards.
  • Collaborate with Regulatory, Quality, and Commercial teams to ensure alignment.
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