Senior Associate, CMC Regulatory

The Position

The Senior Associate, Regulatory CMC supports the execution of regulatory change control and post-approval lifecycle management activities. This role evaluates manufacturing and quality-related changes, assesses potential regulatory impact, and supports the preparation and coordination of regulatory submissions in accordance with global health authority requirements.

The Senior Associate applies scientific, risk-based principles, including relevant concepts outlined in ICH Q12, to support efficient and compliant post-approval change management. Working closely with Regulatory CMC, Quality, Manufacturing, Supply Chain, and external partners, this position helps ensure that CMC changes are appropriately evaluated, documented, communicated, and implemented.

The ideal candidate has practical Regulatory CMC experience, a working knowledge of global health authority requirements, and the ability to manage assigned activities with limited oversight while appropriately escalating significant issues.

This is a full-time, onsite position at Arrowhead’s site in Verona, WI. 

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.

Requirements

• Bachelor’s degree in a scientific, engineering, regulatory, or related discipline.
• Three to five 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 contributing to a major variation or amendment, or supporting an initial NDA or BLA, is preferred.
• Working knowledge of global health authority requirements and regulatory expectations related to CMC development and post-approval lifecycle management.
• Understanding of scientific principles and regulatory CMC requirements relevant to drug development, registration, manufacturing, and post-market support.
• Experience with regulatory information management or CMC lifecycle management systems, such as Veeva Registrations.
• Ability to analyze regulatory and technical information with strong attention to detail.
• Ability to evaluate alternative approaches, identify potential risks, and recommend solutions for review by more senior team members.
• Ability to manage assigned responsibilities with limited oversight and appropriately escalate significant or time-sensitive issues.
• Sound judgment and an understanding of decision-making responsibilities and escalation pathways.
• Strong organizational and project management skills, with the ability to manage multiple priorities and deadlines.
• Demonstrated problem-solving ability, flexibility, accountability, and commitment to teamwork.
• Strong written and verbal communication skills.
• Ability to build effective working relationships and collaborate across functions, sites, and external partners.

Preferred

• Master’s degree or other advanced degree in a scientific, engineering, regulatory, or related discipline.
• Experience supporting both small-molecule and biologic products.
• Familiarity with ICH Q12 and other guidance related to pharmaceutical product lifecycle management.
• Experience working with global manufacturing sites, contract manufacturing organizations, or external suppliers.
• Experience using Veeva Registrations or a comparable regulatory information management system.
• Familiarity with regulatory intelligence research and the application of regulatory precedents.