Executive Director, Regulatory Affairs
Arrowhead Pharmaceuticals
June 25, 2026
On-site
Los Angeles, CA
Corporate Functions
The Position
Executive Director, Regulatory Affairs will lead the Clinical Regulatory sub-team with responsibility for US and ex-US clinical regulatory submissions across the pipeline, with a focus on the EU. Provides global oversight, direction, and leadership for clinical regulatory activities and associated functional support.
Responsibilities
- Provide clinical regulatory expertise and leadership to build credible relationships with health authorities.
- Proactively interact with FDA and other international regulatory agencies; communicate company views.
- Supervise/manage external vendors, contractors, and consultants.
- Obtain/generate information and prepare regulatory planning timelines and submissions; provide subject matter expertise during review of protocols, reports, and documentation.
- Review and interpret regulatory rules; ensure communication through company policies/procedures; recommend and implement compliance strategies.
- Lead development of regulatory infrastructure and business operations (e.g., documentation systems/archiving, publishing systems, templates); own Regulatory Affairs SOPs.
- Back up VP, Regulatory Affairs on core teams; assist with submission risk assessment.
- Manage project budgets (as assigned).
- Occasional domestic and international travel; onsite presence 5 days/week (Pasadena, CA or San Diego, CA; preference Pasadena).
Requirements
- BS in a science-related field (advanced degree preferred).
- 10+ years in a regulated drug environment; management experience ideal.
- In-depth knowledge of drug development regulations (pre-IND through post-approval) and US/ex-US practices.
- Deep understanding of clinical regulatory requirements for trials and marketing applications (EU, UK, Canada, Australia, Asia).
- Knowledge of regional/country-specific requirements for launch and post-approval life-cycle management.
- Track record of successful regulatory filings (IND/CTAs, NDA/BLA/MAAs); several INDs and at least one registrational filing; experience bringing projects to commercialization.
- Experience developing/managing submissions and responses to agency questions.
- Good understanding of pharmaceutical development and the regulatory environment.
Preferred Qualifications
- Experience leading preparations for major regulatory interactions (FDA pre-NDA, EOP2, advisory committee, and/or EU scientific advice).
- Experience with electronic submissions (e.g., Veeva RIM or equivalent); strong MS Word, Adobe Acrobat, and PowerPoint skills.
Application instructions
- Candidates must have current, valid authorization to work in the country where this role is located.
Executive Director, Regulatory Affairs will lead the Clinical Regulatory sub-team with responsibility for US and ex-US clinical regulatory submissions across the pipeline, with a focus on the EU. Provides global oversight, direction, and leadership for clinical regulatory activities and associated functional support.
Responsibilities
- Provide clinical regulatory expertise and leadership to build credible relationships with health authorities.
- Proactively interact with FDA and other international regulatory agencies; communicate company views.
- Supervise/manage external vendors, contractors, and consultants.
- Obtain/generate information and prepare regulatory planning timelines and submissions; provide subject matter expertise during review of protocols, reports, and documentation.
- Review and interpret regulatory rules; ensure communication through company policies/procedures; recommend and implement compliance strategies.
- Lead development of regulatory infrastructure and business operations (e.g., documentation systems/archiving, publishing systems, templates); own Regulatory Affairs SOPs.
- Back up VP, Regulatory Affairs on core teams; assist with submission risk assessment.
- Manage project budgets (as assigned).
- Occasional domestic and international travel; onsite presence 5 days/week (Pasadena, CA or San Diego, CA; preference Pasadena).
Requirements
- BS in a science-related field (advanced degree preferred).
- 10+ years in a regulated drug environment; management experience ideal.
- In-depth knowledge of drug development regulations (pre-IND through post-approval) and US/ex-US practices.
- Deep understanding of clinical regulatory requirements for trials and marketing applications (EU, UK, Canada, Australia, Asia).
- Knowledge of regional/country-specific requirements for launch and post-approval life-cycle management.
- Track record of successful regulatory filings (IND/CTAs, NDA/BLA/MAAs); several INDs and at least one registrational filing; experience bringing projects to commercialization.
- Experience developing/managing submissions and responses to agency questions.
- Good understanding of pharmaceutical development and the regulatory environment.
Preferred Qualifications
- Experience leading preparations for major regulatory interactions (FDA pre-NDA, EOP2, advisory committee, and/or EU scientific advice).
- Experience with electronic submissions (e.g., Veeva RIM or equivalent); strong MS Word, Adobe Acrobat, and PowerPoint skills.
Application instructions
- Candidates must have current, valid authorization to work in the country where this role is located.