Senior Manager, CMC Regulatory Affairs
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Before you apply
Salary$140k – $170k
LocationVerona, WI, Verona, Wisconsin, United States
Work modeon-site
Typefull-time
SenioritySenior
Experience8+ yrs
DepartmentRegulatory
Company size501–1,000 people
PostedMay 6, 2026 · 6mo ago
Verified live8h ago
May no longer be actively hiring
Posted by the company on May 6, 2026
At a glanceSummarised by Seekless from the posting.
BS/BA Degree in a Scientific Discipline
Experience with CMC Life Cycle Management Systems (such as Veeva Registrations)
8+ years of overall biopharmaceutical/device industry experience with 5+ years of direct Regulatory CMC experience
Strong practical experience with global HA requirements
Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support
Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams
Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines
Able to deal with issues of critical importance with minimal oversight
Exercises good judgment in elevating and communicating actual or potential issues to line management
Advanced Degree (M.S., Ph.D., etc.) preferred
Current, valid authorization to work in the country where this role is located
Skills
Veeva Registrations
About the company
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Sr Manager Regulatory CMC ensures efficient and compliant management of regulatory change control and post-approval activities. Supporting diverse modalities—including small molecules, biologics, and external manufacturing sites—the role employs an agile approach to drive standardization, scalability, and sustainability.
This position leverages ICH Q12 principles to streamline post-approval change management. The Sr Manager Regulatory CMC will have good experience with global HA requirements along with an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. The Sr Manager has a proven ability to understand and communicate regulatory strategy for drug development, registration, and post-market support teams.
Responsibilities
Responsibilities
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Lead post-approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes), ensuring compliance with global requirements.
•
Apply science- and risk-based approaches, guided by ICH Q12 principles, to assess and implement post-approval changes.
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Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions.
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Provide centralized regulatory support for manufacturing sites, including external partners, covering small molecules and biologics.
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Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations.
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Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale.
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Facilitate alignment between CMC teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory CMC in cross-functional Change Review meetings.
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Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact.
Requirements
•
BS/BA Degree in a Scientific Discipline,
•
Experience with CMC Life Cycle Management Systems (such as Veeva Registrations)
•
8+ years of overall biopharmaceutical/device industry experience with 5+ years of direct Regulatory CMC experience required. This can include experience leading a major variation/amendment, or supporting an initial NDA/BLA.
•
Strong practical experience with global HA requirements.
•
Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
•
Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
•
Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines.
•
Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management.
Nice to have
Preferred
•
Advanced Degree (M.S., Ph.D., etc.) preferred.
Wisconsin pay range
$140,000—$170,000 USD
Benefits
Arrowhead provides competitive salaries and an excellent benefit package.
Legal
Candidates must have current, valid authorization to work in the country where this role is located.
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