Job Title: Compliance Expert

Arrowhead Pharmaceuticals, Inc. is dedicated to developing innovative medicines that treat complex diseases using RNA interference technology.

We have a broad portfolio of RNA chemistries and efficient modes of delivery to trigger the RNA interference mechanism, inducing rapid, deep, and durable knockdown of target genes.

RNA interference, or RNAi, is a natural pathway of gene silencing present in living cells, inhibiting the expression of a specific gene and affecting protein production.

We are focused on developing life-changing therapies for patients worldwide, addressing conditions in virtually any therapeutic area and pursuing disease targets not addressable by small molecules and biologics.

We lead the field in bringing RNAi to address diseases outside the liver, with a promising pipeline of preclinical candidates.

The Position:

This role ensures compliance with all relevant regulatory requirements and guidelines for multiple global regulatory projects.

Key Responsibilities:

• Assess and communicate regulatory requirements
• Ensure timely and accurate communications of regulatory updates and decisions to internal stakeholders
• Provide regulatory support and guidance to various departments, programs, and teams

Requirements:

• Education equivalent to a BS or MS, plus 5 years of hands-on regulatory experience, or Education equivalent to a higher degree (PhD), plus 3 years of hands-on regulatory experience
• Knowledgeable in ICH and FDA guidelines relevant to device and combination product CMC aspects of product development
• Ability to manage complex projects and timelines in a collaborative matrix team environment
• Effective communication skills and strong negotiation abilities