Senior Associate, CMC Regulatory

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial 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 Senior Associate, Regulatory CMC supports the execution of regulatory change control and post-approval lifecycle management activities. This role evaluates manufacturing and quality-related changes, assesses potential regulatory impact, and supports the preparation and coordination of regulatory submissions in accordance with global health authority requirements.

The Senior Associate applies scientific, risk-based principles, including relevant concepts outlined in ICH Q12, to support efficient and compliant post-approval change management. Working closely with Regulatory CMC, Quality, Manufacturing, Supply Chain, and external partners, this position helps ensure that CMC changes are appropriately evaluated, documented, communicated, and implemented.

The ideal candidate has practical Regulatory CMC experience, a working knowledge of global health authority requirements, and the ability to manage assigned activities with limited oversight while appropriately escalating significant issues.

This is a full-time, onsite position at Arrowhead’s site in Verona, WI.

• Manage assigned post-approval change control activities, including reviewing change records, assessing potential regulatory impact, and supporting related regulatory submissions.
• Evaluate manufacturing, analytical, quality, and supply-related changes against applicable global regulatory requirements and existing product registrations.
• Apply scientific and risk-based approaches, including relevant ICH Q12 principles, when assessing post-approval changes.
• Prepare and maintain clear regulatory assessments, documentation, submission content, and implementation requirements.
• Support the preparation and coordination of global post-approval submissions, including variations, amendments, supplements, notifications, and annual reportable changes.
• Identify opportunities to appropriately group or bundle related changes for review by senior Regulatory CMC colleagues.
• Provide regulatory change control support to internal manufacturing sites, external manufacturing partners, and suppliers across small-molecule and biologic products.
• Collaborate with Quality, Manufacturing, Supply Chain, Technical Operations, and external partners to obtain the information needed to complete regulatory assessments.
• Communicate regulatory requirements, submission commitments, and implementation conditions to relevant stakeholders.
• Participate in cross-functional change review meetings and represent Regulatory CMC for assigned products or change records.
• Support alignment between product CMC…