Associate Director, Materials Compliance

The Position

Let’s do something amazing together! The Materials Compliance Director will play a pivotal role in the commercial launches of Arrowhead’s leading investigational cardiometabolic medicines – Plozasiran (siRNA targeting APOC3) and Zodasiran (siRNA targeting ANGPTL3).  These molecules have demonstrated compelling clinical data to date and are in late-stage development for the treatment of various grievous conditions, including Familial Chylomicronemia Syndrome (FCS), Severe Hypertriglyceridemia (sHTG), Familial Hypercholesterolemia (FH), and cardiovascular disease risk reduction. 

The Materials Compliance Director is responsible for leading and managing the end-to-end Medical/Legal/Regulatory (MLR) review and approval process for educational, promotional, sales training, and disease state materials for assigned products. Reporting into Commercial, this role serves as a critical liaison among Commercial, Medical Affairs, Legal, Regulatory, and external partners to ensure timely, compliant, and high-quality material approvals. This position provides clear leadership and direction across cross functional teams, ensures adherence to regulatory and company standards, and maintains the integrity and neutrality required to balance business objectives with compliance requirements.

This role is based in Pasadena, California, with an expectation to be in office 5 days a week.

Responsibilities

Materials Review Leadership and Oversight

• Lead the Medical/Legal/Regulatory (MLR) review process for assigned products from pre-submission through final approval.
• Act as the primary day to day liaison between material owners, agencies, MLR reviewers, Commercial, and Medical Affairs to ensure timely, compliant, and high-quality material approvals.
• Maintain integrity of neutrality while balancing the needs of all stakeholders and compliance requirements.

Process Management, Technology, and Continuous Improvement

• Provide guidance to material sponsors and reviewers on submission standards (i.e., File Standards), required documentation, and review expectations to ensure materials are complete, compliant, and ready for review.
• Oversee quality control of submitted and final materials, including verification of references, accuracy, and incorporation of required modifications prior to approval.
• Serve as the business owner for Veeva PromoMats, partnering with IS to evaluate business needs and platform enhancements while overseeing workflows, document lifecycle activities, and task administration to ensure effective use of the platform for materials review and approval.
• Develop and maintain tracking systems and dashboards to monitor materials in review, approval status, and key timelines.
• Drive process improvement and operational efficiency by leveraging technology, automation, and digital tools to streamline review workflows, enhance transparency, and improve tracking and reporting capabilities.
• Identify opportunities to introduce innovative solutions, system enhancements, and data insights that strengthen the materials review process and support scalable, compliant operations across the organization.

 Compliance and Governance

• Contribute to company compliance initiatives by ensuring all required promotional materials undergo appropriate review prior to dissemination.
• Support audits, inspections, and internal compliance reviews as needed.
• Maintain up to date knowledge of regulatory requirements, industry trends, and electronic submission standards.

 Communication and Collaboration

• Demonstrate strong communication and diplomatic skills when facilitating discussions and resolving conflicting feedback.
• Foster collaborative working relationships across diverse teams to achieve shared objectives.
• Escalate risks or timeline concerns appropriately and proactively.

 Requirements

• Bachelor’s degree in Biochemistry, Chemistry, Biology, or related scientific discipline required.
• A minimum of 8 years in the pharmaceutical industry with at least 5 years in supporting the MLR review process.
• Demonstrated experience managing regulatory submissions and promotional review processes.
• Experience with FDA advertising and promotion requirements.
• Proficiency in Veeva MedComms and PromoMats required.
• Exceptional organizational skills with strong attention to detail.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong project management capabilities.
• High degree of professionalism, integrity, and sound judgment.
• Effective problem solving and ability to adapt to changing priorities.
• Strong interpersonal skills with the ability to work effectively within diverse teams.
• Travel is not required for this role.

Preferred

• Regulatory Affairs Certification through the Regulatory Affairs Professionals Society.
• Experience preparing regulatory submissions including electronic document submissions such as eCTD.