Director, Regulatory Affairs Labeling

This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations. The position offers the opportunity to strengthen responsible execution, improve decision-making, and support sustainable growth within a life sciences environment.

Location: Remote - US based candidates only, no visa sponsorship available.

Responsibilities

• Collaborate with teams to develop a regulatory labeling strategy
• Manage the creation, review, and approval of various labeling materials
• Lead cross-functional Labeling Working Group and Committees
• Stay updated on labeling regulations and advise stakeholders accordingly
• Research competitor labeling to inform the development of new labels
• Ensure accuracy and quality of all labeling documents and content
• Negotiate with regulatory authorities on labeling issues and changes

Requirements

• Bachelor's degree in science or related field
• 12+ years in biotech or pharmaceutical industry focused on product labeling
• Ability to review regulatory documents for accuracy and compliance
• Experience leading cross-functional meetings and strategic discussions
• Expertise in negotiating complex labeling issues
• Strong communication skills and decision-making abilities
• Detail-oriented with excellent organizational skills

Benefits

• Hybrid work schedule with the option to work remotely
• Quarterly travel as needed for meetings and negotiations
• Participation in continuous improvement initiatives for labeling processes
• Opportunities for robust equity awards and competitive cash compensation
• Access to strong benefits and significant learning and development opportunities

Pay

$201,000 – $251,000 annually