CMC Regulatory Lead — Post-Approval Changes

Socket.dev; Verona (WI); On-site; USD 90,000 - 125,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Verona, Wisconsin, is seeking a Senior Associate, Regulatory CMC to support post-approval lifecycle management and regulatory change control.

You will evaluate manufacturing and quality changes and help prepare submissions in line with global health authority requirements. The ideal candidate has direct Regulatory CMC experience and a working knowledge of ICH Q12, with the ability to coordinate across Regulatory CMC, Quality, Manufacturing, and external

Qualifications

• Bachelor’s degree in a scientific, engineering, regulatory, or related discipline.
• 3–5 years of relevant experience in the biopharmaceutical, pharmaceutical, or medical device industry.
• At least three years of direct Regulatory CMC experience.
• Experience supporting post-approval lifecycle management activities, such as variations, amendments, supplements, annual reports, or other CMC-related submissions.
• Experience using regulatory information management systems, such as Veeva Registrations, is preferred.

Responsibilities

• 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 teams and global Regulatory CMC regarding post-approval strategies, submission requirements, and implementation timelines.
• Maintain accurate regulatory information within applicable systems, including Veeva Registrations or other regulatory information management platforms.
• Track assigned activities and communicate potential risks, delays, or compliance concerns to management in a timely manner.
• Contribute to process improvements that increase the efficiency, consistency, and quality of regulatory change control activities.
• Stay current on relevant global regulations, guidance, and regulatory intelligence related to CMC lifecycle management.

Skills

Regulatory CMC experience

Post-approval lifecycle

Regulatory submissions

Global health authority requirements

Regulatory intelligence

Education

Bachelor’s degree in science/engineering/regulatory

Tools

Veeva Registrations

Job description

Arrowhead Pharmaceuticals, Inc. in Verona, Wisconsin, is seeking a Senior Associate, Regulatory CMC to support post-approval lifecycle management and regulatory change control.

You will evaluate manufacturing and quality changes and help prepare submissions in line with global health authority requirements. The ideal candidate has direct Regulatory CMC experience and a working knowledge of ICH Q12, with the ability to coordinate across Regulatory CMC, Quality, Manufacturing, and external