Director, Labeling Operations

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.