Director, Regulatory Affairs (Labeling)
Arrowhead Pharmaceuticals
August 25, 2026
Remote friendly (San Diego, CA)
United States
Corporate Functions
The Position
- 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 development and post-approval to ensure latest requirements and standards are met.
Responsibilities
- Collaborate cross-functionally to develop labeling strategy and lead labeling meetings.
- Lead development, review, approval, and version control of labeling documents (Target Product Labeling, Core Labeling, Regional Labeling) per internal SOPs and external regulatory requirements.
- Provide expertise on key labeling requirements; stay current with labeling guidelines/regulations and advise stakeholders.
- Research labeling in the same therapeutic class (including competitors) to guide labeling text and contingency strategy for negotiations.
- Perform proofreading and departmental QC; ensure labeling deliverable quality (alignment with data, regulatory requirements, consistency across documents).
- Liaise with stakeholders to resolve regulatory issues and labeling changes.
- Partner with Clinical Regulatory and cross-functional teams for labeling supplements/updates and health authority interactions.
- Ensure dissemination of approved labeling documents and supporting documentation.
- Maintain controlled records of labeling changes and communicate updates at implementation.
- Build partnerships across functions to meet strategic business goals.
- Participate in continuous improvement for the end-to-end labeling process.
- Monitor the global regulatory environment and assess impact on labeling activities.
- Facilitate policy development and updates with internal stakeholders.
Requirements
- Bachelor’s degree in life sciences, computer science, or related science discipline.
- 8+ years in biotech/pharma leading product labeling development/maintenance across two or more major geographic areas.
- Knowledge of advertising promotion regulations and FDA guidance with technical experience in drug development and labeling.
- Experience leading cross-functional meetings and strategic discussions, including negotiation with internal stakeholders and regulatory authorities.
- Ability to review regulatory labeling documents for accuracy and compliance; identify deviations/inconsistencies.
- Strong knowledge of document formatting (MS Word, PDFs compliance, validation tools).
- Professionalism, integrity, and diplomacy.
Preferred
- Experience with regulatory information management systems (e.g., Veeva RIM, Registrations).
- Knowledge of emerging technologies, including AI applications in regulatory operations.
- Experience supporting global inspection readiness.
California pay range: $210,000 USD - $240,000 USD
Candidates must have current, valid authorization to work in the country where this role is located.
- 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 development and post-approval to ensure latest requirements and standards are met.
Responsibilities
- Collaborate cross-functionally to develop labeling strategy and lead labeling meetings.
- Lead development, review, approval, and version control of labeling documents (Target Product Labeling, Core Labeling, Regional Labeling) per internal SOPs and external regulatory requirements.
- Provide expertise on key labeling requirements; stay current with labeling guidelines/regulations and advise stakeholders.
- Research labeling in the same therapeutic class (including competitors) to guide labeling text and contingency strategy for negotiations.
- Perform proofreading and departmental QC; ensure labeling deliverable quality (alignment with data, regulatory requirements, consistency across documents).
- Liaise with stakeholders to resolve regulatory issues and labeling changes.
- Partner with Clinical Regulatory and cross-functional teams for labeling supplements/updates and health authority interactions.
- Ensure dissemination of approved labeling documents and supporting documentation.
- Maintain controlled records of labeling changes and communicate updates at implementation.
- Build partnerships across functions to meet strategic business goals.
- Participate in continuous improvement for the end-to-end labeling process.
- Monitor the global regulatory environment and assess impact on labeling activities.
- Facilitate policy development and updates with internal stakeholders.
Requirements
- Bachelor’s degree in life sciences, computer science, or related science discipline.
- 8+ years in biotech/pharma leading product labeling development/maintenance across two or more major geographic areas.
- Knowledge of advertising promotion regulations and FDA guidance with technical experience in drug development and labeling.
- Experience leading cross-functional meetings and strategic discussions, including negotiation with internal stakeholders and regulatory authorities.
- Ability to review regulatory labeling documents for accuracy and compliance; identify deviations/inconsistencies.
- Strong knowledge of document formatting (MS Word, PDFs compliance, validation tools).
- Professionalism, integrity, and diplomacy.
Preferred
- Experience with regulatory information management systems (e.g., Veeva RIM, Registrations).
- Knowledge of emerging technologies, including AI applications in regulatory operations.
- Experience supporting global inspection readiness.
California pay range: $210,000 USD - $240,000 USD
Candidates must have current, valid authorization to work in the country where this role is located.