Senior Associate, CMC Regulatory

Arrowhead Pharmaceuticals•Verona, WI

1d•$90,000 - $125,000•Onsite

About The Position

Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company focused on developing medicines for intractable diseases by silencing the genes that cause them. They utilize a portfolio of RNA chemistries and delivery methods to trigger RNA interference, leading to rapid, deep, and durable knockdown of target genes. Their approach leverages the natural gene silencing mechanism within living cells. Arrowhead is dedicated to developing innovative drugs for genetic diseases, particularly those characterized by the overproduction of disease-involved proteins. Their versatile RNAi technologies allow them to target conditions across various therapeutic areas, including those not addressable by traditional small molecules and biologics. The company is a leader in applying RNAi beyond the liver, with a clinical pipeline targeting liver and lung diseases and a promising preclinical pipeline. Arrowhead's corporate headquarters are in Pasadena, CA, with R&D teams in Madison, WI & San Diego, CA, and a manufacturing facility in Verona, WI. The employees are described as nimble, science-driven innovators collaborating to bring new therapies to patients. The Senior Associate, Regulatory CMC will support the execution of regulatory change control and post-approval lifecycle management. This role involves evaluating manufacturing and quality changes, assessing their regulatory impact, and preparing/coordinating regulatory submissions according to global health authority requirements. The position will apply scientific, risk-based principles, including ICH Q12 concepts, to manage post-approval changes efficiently and compliantly. Collaboration with Regulatory CMC, Quality, Manufacturing, Supply Chain, and external partners is key to ensuring CMC changes are properly evaluated, documented, communicated, and implemented. The ideal candidate will have practical Regulatory CMC experience, knowledge of global health authority requirements, and the ability to work with limited oversight while escalating issues appropriately.

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.
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.
Candidates must have current, valid authorization to work in the country where this role is located.

Nice To Haves

Experience contributing to a major variation or amendment, or supporting an initial NDA or BLA, is 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.

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.