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 and San Diego, CA.  Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. 

The Position

Reporting to the Executive Director, CMC regulatory, this position will provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs for development products. This will include the preparation or authoring of CMC regulatory investigational, commercial and post approval submissions, participation in the preparation and execution of health authority interactions, assessing the impact of new regulations, etc. The position will also provide direction and strategical guidance on the interpretation and implementation of global CMC regulations to various sub teams.

Responsibilities

Prepare and review submission-ready CMC sections for INDs, CTAs, IND annual reports, IMPD, NDA and MAA applications As a member of the project teams, provide CMC regulatory guidance for global development and registration programs (e.g. INDs, CTAs, NDAs and MAAs) Assess and communicate CMC regulatory requirements to ensure all development activities are conducted in compliance with applicable regulations and guidelines Manage and ensure compliance with all reporting requirements, including annual and periodic reports Provide regulatory support and guidance to various departments, programs, and teams with a strong emphasis on frequent interactions with technical teams Representing the Regulatory Affairs CMC function on assigned cross-functional project teams. Review technical documentation to ensure regulatory compliance and conformance with existing regulatory applications and approvals Research and analyze regulatory information and maintain current regulatory knowledge

Requirements:

B.S. in biochemistry, chemistry, biology or related pharmaceutical field Minimum of 5 years CMC regulatory affairs experience (or equivalent) Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development Ability to manage complex projects and timelines in a collaborative matrix team environment Excellent analytical skills Ability to communicate effectively (verbal and written) to multiple levels in the organization with strong negotiation skills Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors Demonstrated ability to excel in smaller entrepreneurial organizations Wisconsin pay range $140,000—$180,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.   

All applicants must have authorization to work in the US for a company.   

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