Director, Regulatory Affairs (Labeling)
$210,000–$230,000 year
On-sitePasadena, California, United States
Job Summary
Director of Regulatory Affairs (Labeling) at Arrowhead Pharmaceuticals leads global regulatory labeling strategy as the labeling lead, overseeing end-to-end development, review, and governance of labeling documents (Target Product Labeling, CCDS, USPI, EU SmPC) to ensure compliance with regulatory requirements across geographies. The role collaborates with product development, clinical, medical, market access, and commercial teams to generate phase- and time-appropriate labeling content, negotiates with health authorities, maintains controlled labeling records, and supports labeling supplements, updates, and health authority interactions. The position reports to the Executive Director of Clinical Regulatory Strategy and has line reports; responsibilities include cross-functional labeling strategy, document control, stakeholder communication, continuous improvement of the labeling process, and monitoring the global regulatory environment to inform labeling strategy.
Required Qualifications
- Bachelor’s degree in life sciences, computer science, or related science discipline
- Minimum 8+ in the biotech or pharmaceutical industry leading the development/maintenance of product labeling across two or more major geographic areas.
- Knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labeling
- Experience leading cross-functional meetings and facilitating strategic discussions, such as negotiating with internal stakeholders and regulatory authorities on complex labeling issues.
- Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deviations and inconsistencies.
- Strong knowledge of document formatting (MS Word documents, PDFs compliance, and validation tools)
- Ability to maintain highest degree of professionalism, integrity and diplomacy
- Preferred
- Experience with regulatory information management systems (e.g., Veeva RIM, Registrations).
- Knowledgeable in emerging technologies, including AI applications in regulatory operations.
- Experience supporting global inspection readiness.
- California pay range
- Arrowhead provides competitive salaries and an excellent benefit package.
- Candidates must have current, valid authorization to work in the country where this role is located.
- California Applicant Privacy Policy
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.