Global Regulatory Labeling Lead

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

Benefits offered by this job

Competitive salary

Excellent benefits

Job summary

Arrowhead Pharmaceuticals, Inc. in San Diego is seeking a Director of Regulatory Affairs to lead global regulatory labeling strategy and end-to-end labeling development and execution.

You will manage Target Product Labeling, Core Labeling, and regional labeling while ensuring compliance with evolving guidelines. The ideal candidate collaborates with product, clinical development, medical, market access, and commercial teams, negotiates with health authorities, and brings global regulatory

Qualifications

• Bachelor’s degree in life sciences or related field.
• 8+ years in biotech/pharma labeling across two or more geographies.
• Knowledge of FDA guidance and advertising/promotions regulations.
• Experience leading cross-functional labeling meetings and negotiations with regulators.
• Ability to ensure accuracy of labeling documents and alignment with data.

Responsibilities

• Lead cross-functional labeling strategy and labeling meetings.
• Oversee development, review, and version control of labeling documents (TPL, CCDS, US/EU labeling).
• Provide guidance on labeling requirements and regulatory guidelines.
• Analyze competitor labeling to inform strategy and contingency plans.
• Ensure proofreading and QC of labeling deliverables for regulatory compliance.
• Coordinate input from stakeholders and manage labeling updates and implementations.
• Partner with Clinical Regulatory and cross-functional teams for labeling supplements.
• Maintain controlled records of labeling changes and communicate updates.
• Foster partnerships to meet strategic business goals through labeling.
• Support continuous improvement in the end-to-end labeling process.
• Monitor regulatory environment and assess impact on labeling activities.

Skills

Cross-functional leadership

Regulatory labeling

Negotiation with authorities

Regulatory compliance

Education

Bachelor’s degree in life sciences or related discipline

Tools

Veeva RIM

Regulatory document tools

Job description

Arrowhead Pharmaceuticals, Inc. in San Diego is seeking a Director of Regulatory Affairs to lead global regulatory labeling strategy and end-to-end labeling development and execution.

You will manage Target Product Labeling, Core Labeling, and regional labeling while ensuring compliance with evolving guidelines. The ideal candidate collaborates with product, clinical development, medical, market access, and commercial teams, negotiates with health authorities, and brings global regulatory