Director, Regulatory Affairs (Labeling)

Arrowhead Pharmaceuticals•Pasadena, CA

2d•$210,000 - $230,000

About The Position

Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company focused on developing medicines for intractable diseases by silencing the genes that cause them. Utilizing a range of RNA chemistries and delivery methods, their therapies activate the RNA interference mechanism to achieve rapid, deep, and durable knockdown of target genes. RNA interference (RNAi) is a natural cellular process that inhibits specific gene expression, thereby impacting protein production. Arrowhead's RNAi-based therapeutics harness this natural gene silencing pathway. The company is dedicated to creating innovative drugs for genetic diseases, often characterized by the overproduction of disease-related proteins. Their versatile RNAi technologies have the potential to address conditions across virtually any therapeutic area and target diseases that are otherwise inaccessible to small molecules and biologics. Arrowhead is a leader in applying RNAi to diseases beyond the liver, with a clinical pipeline targeting liver and lung diseases, as well as promising preclinical candidates. The company's headquarters are in Pasadena, CA, with R&D teams in Madison, WI & San Diego, CA, and a manufacturing facility in Verona, WI. Arrowhead employees are described as nimble, science-driven innovators collaborating to develop new therapies for patients.

Requirements

Bachelor’s degree in life sciences, computer science, or related science discipline
Minimum 8+ in the biotech or pharmaceutical industry leading the development/maintenance of product labeling across two or more major geographic areas.
Knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labeling
Experience leading cross-functional meetings and facilitating strategic discussions, such as negotiating with internal stakeholders and regulatory authorities on complex labeling issues.
Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deviations and inconsistencies.
Strong knowledge of document formatting (MS Word documents, PDFs compliance, and validation tools)
Ability to maintain highest degree of professionalism, integrity and diplomacy

Nice To Haves

Experience with regulatory information management systems (e.g., Veeva RIM, Registrations).
Knowledgeable in emerging technologies, including AI applications in regulatory operations.
Experience supporting global inspection readiness.

Responsibilities

Collaborate cross-functionally to develop labeling strategy and lead cross-functional Labeling meetings.
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.
Partner with Clinical Regulatory and cross-functional teams to support labeling supplements and updates, and health authority interactions related to labeling.
Ensure the dissemination of approved labeling documents and supporting documentation.
Maintain controlled records for all labeling changes and communicate labeling updates to stakeholders at the time of implementation.
Build partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
Participate in any relevant continuous improvement efforts for the end-to-end labeling process.
Monitor global regulatory environment and assess impact of changes on business and product labeling activities.
Facilitate policy development and updates with internal stakeholders.