Manager/Sr. Manager, Regulatory Affairs

Company: Arrowhead Pharmaceuticals, Inc
Location: Pasadena
Posted on: May 3, 2025

Job Description:

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.The PositionThis position is responsible for supporting multiple global regulatory projects, ensuring compliance with all relevant regulatory requirements and guidelines, and developing and executing regulatory plans. This position will report to the Director, Regulatory Affairs and collaborate with regulatory and other departments to ensure alignment and consistency in regulatory strategies and submissions.Responsibilities

• Lead the preparation and submission of regulatory filings (e.g., IND, CTA/IMPD, annual reports/progress reports, briefing documents, etc.)
• 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.
• Work with global regulatory lead to create and maintain submission project plans, content plans, and responsibility matrices to ensure consistency and completeness to standards for all regulatory submissions.
• Work with regulatory leads to monitor timelines and key program activities and track 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.
• Research and analyze regulatory information and maintain current regulatory knowledge.Requirements
  • Education equivalent to a BS or MS, plus 5 years of hands-on regulatory experience.
  • Education equivalent to a higher degree (PharmD or PhD), plus 3 years of hands-on regulatory experience.
  • Knowledgeable in ICH and FDA guidelines relevant to device and combination product CMC aspects of product development.
  • Ability to manage complex projects and timelines in a collaborative matrix team environment.
  • Ability to communicate effectively (verbal and written) to multiple levels in the organization with strong negotiation skills.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Demonstrated ability to excel in smaller entrepreneurial organizations.Preferred
    • Experience with international regulatory submissions.
    • Experience using Veeva RIM and SmartSheets.$140,000 - $180,000 USDArrowhead provides competitive salaries and an excellent benefits package.All applicants must have authorization to work in the US for a company.
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Keywords: Arrowhead Pharmaceuticals, Inc, Glendora , Manager/Sr. Manager, Regulatory Affairs, Executive , Pasadena, California