Senior Manager, Global CMC Regulatory Affairs & Change

Arrowhead Pharmaceuticals, Inc; Verona (WI); On-site; USD 140,000 - 170,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc, located in Verona, WI, is seeking a Senior Manager Regulatory CMC to ensure efficient management of regulatory change control and post-approval activities. This pivotal role requires extensive experience in biopharmaceuticals as well as a strong understanding of global HA requirements. The candidate will lead activities that drive standardization and compliance, working in a dynamic, collaborative environment. This position offers a salary range of $140,000 — $170,000 USD and an excellent benefits package.

Qualifications

• 8+ years of overall biopharmaceutical/device industry experience.
• 5+ years of direct Regulatory CMC experience.
• Proven ability to understand and communicate regulatory strategy.

Responsibilities

• Lead post-approval change management activities.
• Collaborate with external manufacturing sites to align change control processes.
• Implement streamlined workflows for regulatory change control.

Skills

Regulatory strategy communication

Post-approval change management

Global HA requirements

CMC Life Cycle Management Systems

Scientific understanding

Education

BS/BA Degree in a Scientific Discipline

Advanced Degree (M.S., Ph.D., etc.) preferred

Tools

Veeva Registrations

Job description

Arrowhead Pharmaceuticals, Inc, located in Verona, WI, is seeking a Senior Manager Regulatory CMC to ensure efficient management of regulatory change control and post-approval activities. This pivotal role requires extensive experience in biopharmaceuticals as well as a strong understanding of global HA requirements. The candidate will lead activities that drive standardization and compliance, working in a dynamic, collaborative environment. This position offers a salary range of $140,000 — $170,000 USD and an excellent benefits package.