Director, Labeling Operations

Company: Proclinical Group
Location: Boston
Posted on: February 22, 2025

Job Description:

Director of Labeling Operations - Permanent - Boston, MAProclinical 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.The Director of Labeling 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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Keywords: Proclinical Group, Boston , Director, Labeling Operations, Executive , Boston, Massachusetts