Director, Global Labeling Regulatory

Position Summary:

Director, Global Labeling Regulatory orchestrates global development, maintenance, and compliance of product labeling throughout a drug's lifecycle; manages direct reports and partners cross-functionally to ensure investigational/marketed drug labeling meets global health authority requirements.

Essential Functions / Responsibilities:

• Manage creation/execution of global labeling strategies from early clinical through commercialization.
• Lead day-to-day team activities (hire/train, coach, monitor performance).
• Prepare/maintain key labeling documents (USPI, EU SmPC).
• Ensure labeling content/artwork complies with health authority regulations and GMP (monitor changes and implement updates).
• Manage updates to label content/artwork for packaging/supplies with manufacturing and third-party vendors.
• Review/approve label proofs from internal/external teams.
• Oversee/advise label content negotiations with Regulatory Agencies.
• Draft/lead responses to health authority comments/questions on labeling issues.
• Collaborate on global labeling/CMC matters; manage labeling change controls.
• Oversee/draft label technical specifications; may train Regulatory Affairs SOPs/templates.
• Perform ad-hoc/cross-functional projects as needed.

Education & Experience (Required/Preferred):

• Bachelor’s (14+ years) or Master’s (12+ years) in life sciences/technical discipline.
• Required: extensive Global Health Authority regulatory labeling experience (clinical + commercial).
• Plus: eCTD CMC module preparation/submission.
• Preferred: managing staff; Veeva Vault.

Skills/Knowledge:

• Biologic-based drug labeling expertise (cell/gene therapies, antibodies, recombinant proteins).
• Leadership, complex matrix experience, deadline management.
• Electronic document management proficiency; strong communication/organization; cultural sensitivity.

Benefits (as stated):

• Medical/Dental/Vision
• wellness programs
• EAP
• life/AD&D
• short/long-term disability
• FSAs
• 401(k) match
• 529
• PTO/holidays