Director, Regulatory Affairs (Labeling)
Arrowhead Pharmaceuticals
August 09, 2026
Remote friendly (San Diego, CA)
United States
Corporate Functions
The Director of Regulatory Affairs is Arrowhead’s labeling lead, driving cross-functional development and execution of global regulatory labeling strategy. Manage regulatory labeling end-to-end through all phases of development and post-approval.
Responsibilities:
- Collaborate cross-functionally to develop labeling strategy and lead labeling meetings.
- Manage development, review, approval, and version control of labeling documents (Target Product Labeling, Core Labeling/CCDS, Regional Labeling/USPI, EU SmPC).
- Maintain expertise in key labeling requirements and advise stakeholders on labeling principles.
- Research competitor labels within the therapeutic class and develop contingency strategies for negotiations with health authorities.
- Perform proofreading/QC to ensure labeling deliverable quality (data alignment, regulatory compliance, document consistency).
- Liaise with stakeholders to obtain labeling input; resolve key regulatory issues and labeling changes.
- Support labeling supplements/updates and health authority interactions.
- Ensure dissemination of approved labeling documents and supporting documentation.
- Maintain controlled records for labeling changes and communicate updates at implementation.
- Participate in continuous improvement for end-to-end labeling.
- Monitor the global regulatory environment and assess impact on labeling activities.
- Facilitate internal policy development and updates.
Requirements:
- Bachelor’s degree in life sciences, computer science, or related science.
- 8+ years leading product labeling development/maintenance in biotech/pharma across two+ major geographic areas.
- Knowledge of advertising/promotion regulations and FDA guidance (with technical drug development/labeling experience).
- Experience leading cross-functional meetings and strategic negotiations with internal stakeholders/regulatory authorities.
- Ability to review labeling documents for accuracy and regulatory adherence.
- Strong document formatting knowledge (MS Word, PDFs compliance, validation tools).
- Professionalism, integrity, and diplomacy.
Preferred:
- Regulatory information management systems (e.g., Veeva RIM, Registrations).
- AI applications in regulatory operations.
- Experience supporting global inspection readiness.
California pay range: $210,000 USD - $230,000 USD.
Candidates must have current, valid authorization to work in the country where this role is located.
Responsibilities:
- Collaborate cross-functionally to develop labeling strategy and lead labeling meetings.
- Manage development, review, approval, and version control of labeling documents (Target Product Labeling, Core Labeling/CCDS, Regional Labeling/USPI, EU SmPC).
- Maintain expertise in key labeling requirements and advise stakeholders on labeling principles.
- Research competitor labels within the therapeutic class and develop contingency strategies for negotiations with health authorities.
- Perform proofreading/QC to ensure labeling deliverable quality (data alignment, regulatory compliance, document consistency).
- Liaise with stakeholders to obtain labeling input; resolve key regulatory issues and labeling changes.
- Support labeling supplements/updates and health authority interactions.
- Ensure dissemination of approved labeling documents and supporting documentation.
- Maintain controlled records for labeling changes and communicate updates at implementation.
- Participate in continuous improvement for end-to-end labeling.
- Monitor the global regulatory environment and assess impact on labeling activities.
- Facilitate internal policy development and updates.
Requirements:
- Bachelor’s degree in life sciences, computer science, or related science.
- 8+ years leading product labeling development/maintenance in biotech/pharma across two+ major geographic areas.
- Knowledge of advertising/promotion regulations and FDA guidance (with technical drug development/labeling experience).
- Experience leading cross-functional meetings and strategic negotiations with internal stakeholders/regulatory authorities.
- Ability to review labeling documents for accuracy and regulatory adherence.
- Strong document formatting knowledge (MS Word, PDFs compliance, validation tools).
- Professionalism, integrity, and diplomacy.
Preferred:
- Regulatory information management systems (e.g., Veeva RIM, Registrations).
- AI applications in regulatory operations.
- Experience supporting global inspection readiness.
California pay range: $210,000 USD - $230,000 USD.
Candidates must have current, valid authorization to work in the country where this role is located.