Director, Regulatory Affairs (Labeling)
Arrowhead Pharmaceuticals
August 25, 2026
Remote friendly (Pasadena, 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. Manages regulatory labeling end-to-end through development and post-approval to meet the latest requirements and standards.
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 [e.g., CCDS], Regional Labeling [e.g., USPI, EU SmPC]) per SOPs and external requirements.
- Provide expertise on key labeling requirements; stay current on labeling guidelines/regulations.
- Research competitor/therapeutic class labels to guide labeling text and develop contingency strategies for health authority negotiations.
- Perform proofreading and QC to ensure labeling quality and consistency with data and regulatory requirements.
- Liaise with stakeholders to obtain labeling input and resolve regulatory issues/changes.
- Support labeling supplements/updates and health authority interactions.
- Ensure dissemination of approved labeling and supporting documentation.
- Maintain controlled records of labeling changes and communicate updates at implementation.
- Support continuous improvement of the end-to-end labeling process.
- Monitor global regulatory environment and assess impact on labeling activities; facilitate internal policy updates.
Requirements:
- Bachelor’s degree in life sciences, computer science, or related science.
- 8+ years leading product labeling development/maintenance across 2+ major geographic areas.
- Knowledge of advertising promotion regulations and FDA guidance with technical experience in drug development/labeling.
- Experience leading cross-functional meetings and negotiating with internal stakeholders/regulatory authorities.
- Ability to review labeling for accuracy and regulatory adherence (noting deviations/inconsistencies).
- Strong document formatting knowledge (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/AI in regulatory operations.
- Experience supporting global inspection readiness.
California pay range: $210,000–$240,000.
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.
- Lead 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 SOPs and external requirements.
- Provide expertise on key labeling requirements; stay current on labeling guidelines/regulations.
- Research competitor/therapeutic class labels to guide labeling text and develop contingency strategies for health authority negotiations.
- Perform proofreading and QC to ensure labeling quality and consistency with data and regulatory requirements.
- Liaise with stakeholders to obtain labeling input and resolve regulatory issues/changes.
- Support labeling supplements/updates and health authority interactions.
- Ensure dissemination of approved labeling and supporting documentation.
- Maintain controlled records of labeling changes and communicate updates at implementation.
- Support continuous improvement of the end-to-end labeling process.
- Monitor global regulatory environment and assess impact on labeling activities; facilitate internal policy updates.
Requirements:
- Bachelor’s degree in life sciences, computer science, or related science.
- 8+ years leading product labeling development/maintenance across 2+ major geographic areas.
- Knowledge of advertising promotion regulations and FDA guidance with technical experience in drug development/labeling.
- Experience leading cross-functional meetings and negotiating with internal stakeholders/regulatory authorities.
- Ability to review labeling for accuracy and regulatory adherence (noting deviations/inconsistencies).
- Strong document formatting knowledge (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/AI in regulatory operations.
- Experience supporting global inspection readiness.
California pay range: $210,000–$240,000.
Candidates must have current, valid authorization to work in the country where this role is located.