Executive Director, Regulatory Affairs

Arrowhead Pharmaceuticals•San Diego, CA

13h•Onsite

About The Position

Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company dedicated to developing medicines for intractable diseases by silencing the genes that cause them. The company utilizes a broad portfolio of RNA chemistries and efficient delivery methods to trigger the RNA interference mechanism, leading to rapid, deep, and durable knockdown of target genes. Arrowhead focuses on innovative drugs for diseases with a genetic basis, particularly those characterized by the overproduction of proteins involved in disease. Their RNAi technologies allow them to address conditions in various therapeutic areas and pursue targets not accessible by small molecules and biologics, with a clinical pipeline targeting diseases in the liver and lung. The company's corporate headquarters are in Pasadena, CA, with research and development teams in Madison, WI, and San Diego, CA, and a manufacturing facility in Verona, WI. The Executive Director, Regulatory Affairs, will report to the Group Vice President, Regulatory Affairs, and will lead the Clinical Regulatory sub-team. This role encompasses responsibility for Clinical Regulatory submissions in the US and ex-US across the entire Arrowhead pipeline, with a specific focus on the EU. The incumbent will provide global oversight, direction, and leadership for all clinical regulatory activities related to assigned products and functional support. Key aspects include actively developing, participating in, and managing the coordination, creation, and review of clinical regulatory strategies and associated documents for submissions, while ensuring compliance with global regulatory requirements, laws, and regulations. This position requires an onsite presence 5 days a week in either Pasadena, CA, or San Diego, CA, with a preference for Pasadena, CA.

Requirements

Bachelor of Science degree in a science-related field (with an advanced scientific degree preferred).
10+ years of relevant experience in a regulated drug environment is required. The ideal candidate will also have management experience.
In-depth understanding of regulations and guidelines governing all phases (pre-IND through post-approval) of drug development and working knowledge of US and ex-US regulations and practices pertaining to the development, manufacture, testing and distribution of pharmaceutical.
In-depth understanding of clinical regulatory requirements for clinical trials and marketing applications particularly for key countries ex-US such as EU, UK, Canada, Australia and Asia.
In-depth understanding of regional/country-specific clinical regulatory requirements for launch requirements and post-approval life cycle management particularly for key countries ex-US such as EU, UK, Canada, Australia and Asia.
A demonstrated track record of successful regulatory filings e.g. IND/CTAs, NDA/BLA/MAAs is essential, with the ideal candidate having done several INDs and at least one registrational filing. Experience with bringing regulatory projects to commercialization is of value.
Demonstrable experience in successfully developing and managing regulatory submissions, review and preparation of scientific/technical/clinical responses to agency questions.
Good understanding of pharmaceutical development, clinical research and the regulatory environment.

Nice To Haves

Previous experience in leading a team to prepare for major regulatory agency interactions, such as FDA pre-NDA, EOP2 meetings, advisory committee meetings, and/or EU oral explanations/scientific advice.
Experience with the electronic submission process (e.g., Veeva RIM System or equivalent); highly proficient in the functionality of MS Word, Adobe Acrobat, and PowerPoint.

Responsibilities

In partnership with the Group Vice President, Regulatory Affairs, provide clinical regulatory expertise and leadership to ensure the Company builds credible and trustworthy relationships with health authorities based upon the submission of scientifically meritorious data and in conformance with quality standards.
Interacts with FDA and other international regulatory agencies as needed, on a proactive, independent, and frequent Appropriately communicates company views to agencies.
Supervise, manage, and collaborate with external service vendors, contractors and consultants as needed.
Obtain, generate information and documents to be submitted to regulatory authorities; prepare effective planning timelines, and liaise 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. 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 Standard Operating Procedures (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.