Director, Regulatory Labeling Operations

Regeneron Pharmaceuticals

88d • $180,400 - $300,700

About The Position

Regeneron is seeking a Director, Regulatory Labeling Operations to join our team! In this role, a typical day might include: The Director, Regulatory Labeling Operations will be responsible for providing oversight to Regulatory Labeling Operations in the development, revision, and approval of packaging component artworks for marketed products as well as products in full development. Oversees the preparation and delivery of submission-ready labeling documents. Manages interface with Manufacturing/Supply Chain, Regulatory Operations, and various labeling vendors (e.g., SPL, translations, QC tool, etc.). Leads or supports labeling content and/or artwork system development and implementation. Supports the creation or revision of labeling SOPs or work instructions.

Requirements

• Bachelor's degree (BS) from an accredited college or university, preferably in the field of Health/Science OR 10+ years of industry experience.
• In-depth knowledge of worldwide Regulatory Agencies, industry practice, packaging manufacturing process, and the drug development process.
• Familiarity with FDA, EMEA, and international packaging regulations and industry practices for biologic and combination product.
• 10-15+ years of Biotech or Pharma industry experience in regulatory labeling and packaging, and some management experience.
• Experience implementing new corporate labeling and/or artwork systems.
• Experience managing labeling process initiatives.
• Ability to lead/advise Cross Functional Packaging Teams to navigate printed component labeling issues, develop plans of action, and resolve complex issues.
• Ability to work independently and use judgment to make decisions and escalate problems appropriately.
• Ability to handle multiple projects and prioritize work independently for self and direct reports.
• Attention to detail and strong word processing and organizational skill.

Responsibilities

• Leading Regulatory Labeling Operations in the development, revision, and approval of packaging component artworks, e.g., carton, container labeling, printed package insert, for full development products as well as marketed products.
• Leading and/or advising Packaging Teams to ensure packaging component content and artworks are compliant with internal labeling policies, standard operating procedures and worldwide health authority regulations and guidance.
• Managing Regulatory Labeling Operations Group and providing training and guidance for direct reports.
• Managing relationships with internal stakeholders such as Manufacturing/Supply Chain, Regulatory Operations, cross functional packaging team members, as well as various labeling vendors (e.g., SPL, translations, readability, QC tool).
• Providing labeling expertise to novel packaging design initiatives.
• Leading and/or collaborating with internal experts to develop & implement labeling content and/or artwork management system solutions.
• Supporting operational labeling deliverables not limited to SPL, EMA translations/linguistic reviews, preparing submission ready labeling documents, proofreading/QC, labeling contributions to periodic reports.
• Monitoring worldwide regulation changes pertaining to Labeling.
• Supporting the creation or revision of labeling SOPs or work instructions.

Benefits

• Health and wellness programs
• Fitness centers
• Equity awards
• Annual bonuses
• Paid time off for eligible employees at all levels

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees