Global Regulatory Affairs Manager — Submissions & Strategy

Arrowhead Pharmaceuticals; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salaries and benefits

Job summary

Arrowhead Pharmaceuticals, Inc. is seeking a dynamic Regulatory Affairs professional to support multiple global regulatory projects, ensuring compliance with applicable requirements and developing regulatory plans.

You will report to the Director, Regulatory Affairs and work with cross‑functional teams to align strategies and submissions. The role focuses on IND/CTA/IMPD filings, health authority interactions, and global submissions, with opportunities to influence product development and

Qualifications

• Bachelor’s or Master’s degree with at least five years of hands-on regulatory experience; or an advanced degree with at least three years.
• Strong knowledge of FDA and international regulatory requirements, regulations, and guidance.
• Proven ability to manage complex projects within a collaborative, cross-functional matrix environment.
• Excellent written and verbal communication skills, with the ability to influence and negotiate effectively across all levels of the organization.
• Strong attention to detail and the ability to work independently, collaboratively within multidisciplinary teams, and effectively with external partners and vendors.

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 experience

Regulatory strategy

Communication

Cross-functional collaboration

Education

Bachelor's or Master’s degree

Advanced degree (PharmD/PhD)

Job description

Arrowhead Pharmaceuticals, Inc. is seeking a dynamic Regulatory Affairs professional to support multiple global regulatory projects, ensuring compliance with applicable requirements and developing regulatory plans.

You will report to the Director, Regulatory Affairs and work with cross‑functional teams to align strategies and submissions. The role focuses on IND/CTA/IMPD filings, health authority interactions, and global submissions, with opportunities to influence product development and