Director, Regulatory Affairs (Labeling)
Arrowhead Pharmaceuticals
June 26, 2026
Remote friendly (Los Angeles, CA)
United States
Corporate Functions
Responsibilities:
- Collaborate cross-functionally to develop labeling strategy and lead cross-functional Labeling meetings.
- Manage development, review, approval, and version control of labeling documents (Target Product Labeling, Core Labeling [e.g., CCDS], Regional Labeling [e.g., USPI, EU SmPC]) per internal SOPs and external regulatory requirements.
- Maintain expertise on key labeling requirements; stay current with labeling guidelines/regulations and advise stakeholders.
- Research and benchmark labeling from the therapeutic class, including competitors; develop contingency strategy for negotiations with health authorities.
- Perform proofreading and departmental QC; ensure labeling deliverable quality (alignment with data, regulatory requirements, consistency across documents).
- Liaise with cross-functional stakeholders to obtain labeling input and resolve regulatory issues and labeling changes.
- Partner with Clinical Regulatory and cross-functional teams to support labeling supplements/updates and health authority interactions.
- Ensure dissemination of approved labeling and supporting documentation.
- Maintain controlled records for labeling changes; communicate updates at implementation.
- Build stakeholder partnerships to achieve 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 internal policy development and updates.
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; some 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 in regulatory operations.
- Experience supporting global inspection readiness.
California pay range: $210,000 USD - $230,000 USD
- Collaborate cross-functionally to develop labeling strategy and lead cross-functional Labeling meetings.
- Manage development, review, approval, and version control of labeling documents (Target Product Labeling, Core Labeling [e.g., CCDS], Regional Labeling [e.g., USPI, EU SmPC]) per internal SOPs and external regulatory requirements.
- Maintain expertise on key labeling requirements; stay current with labeling guidelines/regulations and advise stakeholders.
- Research and benchmark labeling from the therapeutic class, including competitors; develop contingency strategy for negotiations with health authorities.
- Perform proofreading and departmental QC; ensure labeling deliverable quality (alignment with data, regulatory requirements, consistency across documents).
- Liaise with cross-functional stakeholders to obtain labeling input and resolve regulatory issues and labeling changes.
- Partner with Clinical Regulatory and cross-functional teams to support labeling supplements/updates and health authority interactions.
- Ensure dissemination of approved labeling and supporting documentation.
- Maintain controlled records for labeling changes; communicate updates at implementation.
- Build stakeholder partnerships to achieve 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 internal policy development and updates.
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; some 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 in regulatory operations.
- Experience supporting global inspection readiness.
California pay range: $210,000 USD - $230,000 USD