Executive Director, Regulatory Affairs

The Position This position will report into Group Vice President, Regulatory Affairs. The Executive Director, Regulatory Affairs will be the leader of the Clinical Regulatory sub‑team and will have responsibility for Clinical Regulatory submissions in the US and ex‑US across the entire Arrowhead pipeline, with a focus on the EU. The Executive Director, Regulatory Affairs will provide global oversight; direction and leadership for all clinical regulatory activities related to their assigned products as well as any assigned functional support activities. The incumbent will actively develop, participate in, and manage the coordination, creation, and review of clinical regulatory strategies and all associated documents for regulatory submissions. The Executive Director, Regulatory Affairs, will ensure compliance of all associated activities, documentation quality and reporting obligations with relevant global regulatory requirements, laws and regulations. This role requires onsite presence 5 days a week either in Pasadena, CA or San Diego, CA, with a preference for Pasadena, CA. Responsibilities Provide clinical regulatory expertise and leadership to ensure the company builds credible relationships with health authorities based upon scientifically meritorious data in conformance with quality standards. Interact with FDA and other international regulatory agencies proactively and independently, communicating company views effectively. Supervise, manage and collaborate with external service vendors, contractors and consultants as needed. Obtain and generate information and documents to be submitted to regulatory authorities; prepare effective planning timelines and coordinate with team contributors for the preparation of required regulatory documents and submissions. Provide regulatory subject matter expertise during the review of documentation, protocols and reports received and prepare additional written materials as needed. Review and interpret regulatory rules as they relate to company products and procedures, clinical studies, testing or record-keeping and ensure they are communicated through company policies and procedures. Recommend and implement compliance strategies for existing and proposed products and activities. Take a leadership role in the development of regulatory functional infrastructure and business operations, e.g., electronic documentation management systems/archiving, electronic publishing systems, documentation template development; serve as primary owner for Regulatory Affairs SOPs. Serve as backup to the Vice President, Regulatory Affairs on assigned core teams as needed; assist in submission risk assessment process. Handle various project budgets as assigned. Occasional domestic and international travel. Requirements Bachelor of Science degree in a science‑related field (advanced scientific degree preferred). 10+ years of relevant experience in a regulated drug environment required; management experience is preferred. In‑depth understanding of regulations and guidelines governing all phases of drug development and working knowledge of U.S. and ex‑U.S. regulations and practices pertaining to the development, manufacture, testing and distribution of pharmaceuticals. Understanding of clinical regulatory requirements for clinical trials and marketing applications particularly for key ex‑U.S. countries such as EU, UK, Canada, Australia and Asia. Understanding of regional/country‑specific clinical regulatory requirements for launch and post‑approval lifecycle management for key ex‑U.S. countries. Track record of successful regulatory filings (IND/CTAs, NDA/BLA/MAAs) essential; ideal candidate has successfully filed several INDs and at least one registrational filing; experience with bringing regulatory projects to commercialization adds value. Experience developing and managing regulatory submissions, reviewing and preparing scientific/technical/clinical responses to agency questions. Good understanding of pharmaceutical development, clinical research and the regulatory environment. Preferred Qualifications Experience leading a team to prepare for major regulatory agency interactions (FDA pre‑NDA, EOP2 meetings, advisory committee meetings, EU oral explanations/scientific advice). Experience with electronic submission process (Veeva RIM System or equivalent); highly proficient in MS Word, Adobe Acrobat and PowerPoint. California Pay Range $280,000—$320,000 USD Benefits Arrowhead provides competitive salaries and an excellent benefit package. Candidates must have current, valid authorization to work in the country where this role is located. #J-18808-Ljbffr