Global Regulatory Labeling Leader

Arrowhead Pharmaceuticals; Pasadena (CA); On-site; USD 180,000 - 280,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc., headquartered in Pasadena, CA, is seeking a Director of Regulatory Affairs to lead global labeling strategy through development and post-approval. You will collaborate with product, clinical, medical, market access, and commercial teams to draft target product profiles and labeling, negotiate with health authorities, and ensure compliance across regions.

The ideal candidate has extensive experience in regulatory labeling, cross-functional leadership, and global

Qualifications

• Bachelor's degree in life sciences, computer science, or related science discipline.
• Minimum 8+ years in biotech/pharma leading labeling development across two or more major geographies.
• Knowledge of advertising/promo regulations and FDA guidance with experience in drug development labeling.
• Experience leading cross-functional meetings and negotiating labeling issues with stakeholders and authorities.
• Ability to review labeling documents for accuracy and regulatory compliance, noting deviations.
• Strong document formatting knowledge (MS Word, PDFs, validation tools).
• Maintain professionalism, integrity and diplomacy.

Responsibilities

• Collaborate cross-functionally to develop labeling strategy and lead labeling meetings.
• Lead development, review, approval, and version control of labeling documents (TPL, CCDS, US/EU labeling).
• Provide expertise on labeling requirements and regulatory guidelines for development/maintenance.
• Research content of labels in the therapeutic class and competitor labeling to guide labeling text.
• Proofread and QC labeling deliverables for data alignment and regulatory compliance.
• Coordinate with cross-functional stakeholders to resolve regulatory issues and labeling changes.
• Support labeling supplements and health authority interactions related to labeling.
• Disseminate approved labeling documents and supporting documentation.
• Maintain controlled records for all labeling changes and communicate updates to stakeholders.
• Build partnerships with other functions to support business goals with labeling.
• Participate in continuous improvement of end-to-end labeling process.
• Monitor global regulatory environment and assess impact on labeling activities.
• Facilitate policy development and updates with internal stakeholders.

Skills

Cross-functional

Labeling strategy

Regulatory negotiation

Documentation review

Education

Bachelor's degree

8+ years labeling

Job description

Arrowhead Pharmaceuticals, Inc., headquartered in Pasadena, CA, is seeking a Director of Regulatory Affairs to lead global labeling strategy through development and post-approval. You will collaborate with product, clinical, medical, market access, and commercial teams to draft target product profiles and labeling, negotiate with health authorities, and ensure compliance across regions.

The ideal candidate has extensive experience in regulatory labeling, cross-functional leadership, and global