Boston - Director, Labeling Operations

placeBoston calendar_month 

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.

The 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.

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at n.walker@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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