Director, Regulatory Affairs (Labeling, Advertising and Promotion)

Arrowhead Pharmaceuticals•Pasadena, CA

1d•$210,000 - $230,000

About The Position

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 Director provides strategic and operational leadership for regulatory labeling and promotional activities. As the labeling lead, the Director will be responsible for the cross-functional development and execution of global regulatory labeling strategy for Arrowhead’s pipeline, late stage, and marketed products. This individual will manage regulatory labeling through all phases of development, during review and approval by regulators, and post-approval, ensuring that the latest requirements and standards are met. The Director is also responsible for working together with legal, medical affairs and applicable stakeholders to ensure that promotional review and practices are consistent with applicable regulatory requirements, guidelines, company policies, and procedures. The Director will provide guidance, review and approve materials related to US promotional and advertising campaigns for marketed products and serve as the regulatory lead or co-lead on the US Promotional Review Committee (PRC/PCRC/MRC). The Director position will report into the Executive Director of Clinical Regulatory Strategy and have line reports.

Requirements

Bachelor’s degree in life sciences, computer science, or related science discipline
10+ 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

Nice To Haves

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.

Responsibilities

Manage development, review, approval, and version control of labeling documents, including Target Product Labeling, Core Labeling (e.g., Company Core Data Sheet [CCDS]), and Regional Labeling (e.g., USPI, EU SmPC), in a timely manner according to internal SOPs and external regulatory requirements.
Maintain expertise regarding key labeling requirements and stay current with labeling guidelines/regulations as they pertain to the development/maintenance of labeling and advise key stakeholders on the application of these labeling principles.
Research the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text, including contingency strategy development for negotiation with regulatory authorities.
Responsible for proofreading and departmental QC work; ensure quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency between labeling documents).
Liaise with cross functional members and stakeholders to obtain input pertaining to labeling including resolution of key regulatory issues and labeling changes.
Provide operational oversight for MRC and PRC activities, generate SOPs, and conduct process improvement for advertising and promotional review
This position requires frequent interaction and strong collaboration with Commercial, Medical Affairs, and Legal, for the purpose of providing regulatory advice and guidance during promotional plan development
Responsible for leading interactions and all submissions to FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB), including the timely and accurate FDA 2253 submissions of US promotional materials