Regulatory
Associate Director, Global Regulatory Operations (Regulatory Submissions and Publishing)
Office Location: Pasadena, CA
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 & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Associate Director, Regulatory Operations, is responsible for strategic and operational leadership of complex submissions, publishing, and regulatory information management systems. This role ensures the delivery of high-quality, compliant regulatory dossiers. This role ensures the delivery of high-quality, compliant regulatory dossier to FDA and global health authorities.
The Associate Director serves as a subject matter expert in electronic submissions (eCTD), publishing systems, and regulatory operation infrastructure, driving submission excellence, process optimization, compliance readiness, and system innovation across the Regulatory organization.
Responsibilities
- Provide operational leadership and oversight for global regulatory submissions, ensuring compliance with applicable regional regulations and technical requirements. Oversee preparation, publishing, quality control, and transmission of electronic submissions (eCTD) for INDs, NDAs, CTAs, MAAs, and post-approval submissions
- Ensure submissions deliverables meet health authority formatting, validation, and technical standards
- Own and oversee regulatory publishing systems and regulatory information management systems (e.g., Veeva RIM), ensuring system integrity, compliance, and optimization.
- Establish and maintain standardized processes for document formatting, publishing workflows, submission validation, and archiving.
- Oversee regulatory archiving and document retention practices in accordance with global regulatory requirements.
- Evaluate and implement system enhancements, automation, and emerging technologies to improve efficiency and compliance.
- Develop and maintain SOPs and work instructions related to regulatory operations and publishing.
- Serve as the regulatory operations expert to advise teams on submission standards, timelines for technical preparation, and health authority expectations.
- Partner closely with Medical Writing, Regulatory Affairs, Quality, Clinical Operations, and external partners/vendors to ensure clarify of submissions requirements and operational readiness.
- Perform quality control checks and work with the subject matter expert to address findings
- Identify and resolve formatting, technical, and compliance issues related to publishing manners in collaboration with subject matter experts
- Manage Arrowhead’s archiving and document retention processes, in accordance with regulations and inspection readiness.
Requirements
- Bachelor’s degree in life sciences, computer science, or related science discipline
- 8+ years of relevant experience in pharmaceutical, biotechnology, or life sciences industry, including leadership experience in Regulatory Affairs Operations and Publishing
- Deep expertise in electronic submission requirements (eCTD and regional variations)
- Strong knowledge of document formatting (MS Word documents, PDFs compliance, and validation tools)
- Experience preparing and publishing high-quality electronic regulatory dossiers with major health authorities
- Demonstrated understanding of regulatory systems from both business process and end-user perspectives.
- Ability to maintain highest degree of professionalism, integrity and diplomacy
Preferred
- Experience with regulatory information management systems (e.g., Veeva RIM).
- Knowledgeable in emerging technologies, including AI applications in regulatory operations.
- Ability to serve as senior publishing SME and technical escalation point
- Experience supporting global inspection readiness.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.