Global Regulatory Strategy Lead

Arrowhead Pharmaceuticals; Los Angeles (CA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefits

Job summary

Arrowhead Pharmaceuticals, Inc. in the United States is seeking a Regulatory Affairs professional to lead and coordinate global regulatory filings and strategies.

You will ensure compliance with FDA and international guidelines and partner with cross-functional teams to align regulatory plans with development goals. The role emphasizes managing submissions (IND/CTA), communicating regulatory updates, and driving timely outcomes in a fast-paced, entrepreneurial environment.

Qualifications

• Bachelor’s or Master’s degree with at least five years of hands-on regulatory experience.
• PharmD, PhD, or other advanced degree with at least three years of hands-on regulatory experience.
• Strong knowledge of FDA and international regulatory requirements, regulations, and guidance.

Responsibilities

• Lead the preparation and submission of regulatory filings (e.g., IND, CTA/IMPD, annual reports/progress reports, briefing documents, etc.).
• Execute regulatory strategies to support product development, approval, and commercialization, ensuring alignment with the company's goals and objectives.
• Participate or lead the preparation for Health Authority interactions
• Collaborate with the global regulatory lead and regional regulatory affiliates (and consultants) in preparation and submission of global marketing authorization applications.
• Create and maintain submission project plans, content plans, and responsibility matrices to ensure consistency and completeness to standards for all regulatory submissions.
• Monitor timelines and key program activities and tracking submission deliverables to maintain target submission dates.
• Assess and communicate regulatory requirements to ensure all development activities are conducted in compliance with applicable regulations and guidelines
• Ensure timely and accurate communications of regulatory updates and decisions to internal stakeholders.
• Provide regulatory support and guidance to various departments, programs, and teams with a strong emphasis on frequent interactions with technical teams
• Review technical documentation to ensure regulatory compliance and conformance with existing regulatory applications and approvals
• Monitor for and integrate regulatory intelligence/guidelines into program strategies and contribute to risk identification and mitigation planning within development teams
• Research and analyze regulatory information and maintain current regulatory knowledge

Skills

Regulatory affairs

FDA knowledge

Project management

Cross-functional collaboration

Communication skills

Education

Bachelor's or Master’s degree

PharmD/PhD or advanced degree

Job description

Arrowhead Pharmaceuticals, Inc. in the United States is seeking a Regulatory Affairs professional to lead and coordinate global regulatory filings and strategies.

You will ensure compliance with FDA and international guidelines and partner with cross-functional teams to align regulatory plans with development goals. The role emphasizes managing submissions (IND/CTA), communicating regulatory updates, and driving timely outcomes in a fast-paced, entrepreneurial environment.