Director, Regulatory Labeling Operations

Role Summary

Director, Regulatory Labeling Operations at Regeneron. Oversees regulatory labeling operations for packaging component artworks and submission-ready labeling documents across development and marketed products.

Responsibilities

• Lead and oversee the development, revision, and approval of packaging component artworks (e.g., carton, container labeling, printed package insert) for full development and marketed products.
• Oversee preparation and delivery of submission-ready labeling documents.
• Manage interfaces with Manufacturing/Supply Chain, Regulatory Operations, and labeling vendors (e.g., SPL, translations, QC tool).
• Lead or support labeling content and artwork system development and implementation.
• Support creation or revision of labeling SOPs or work instructions.

Qualifications

• Required: Bachelor's degree (BS) from an accredited college or university, preferably in Health/Science, or 10+ years of industry experience.
• In-depth knowledge of worldwide regulatory agencies, industry practice, packaging manufacturing processes, and the drug development process; familiarity with FDA, EMEA, and international packaging regulations for biologic and combination products.
• 10-15+ years of biotech or pharma industry experience in regulatory labeling and packaging, with some management experience.
• Experience implementing new corporate labeling and/or artwork systems.
• Experience managing labeling process initiatives.
• Ability to lead/advice cross-functional packaging teams to navigate labeling issues, develop action plans, and resolve complex problems.
• Ability to work independently, make decisions, and escalate problems as needed.
• Ability to manage multiple projects and prioritize work for self and direct reports.
• Attention to detail and strong word processing and organizational skills.

Skills

• Regulatory labeling and packaging expertise
• Artwork systems and labeling content management
• Cross-functional collaboration with Manufacturing/Supply Chain and regulatory teams
• Vendor management (SPL, translations, readability, QC tools)
• Project management and process improvement

Education

• Bachelor's degree (BS) in Health/Science or related field (preferred)

Additional Requirements

• Travel expectations not specified