- Location
- Verona, Wisconsin, United States · Verona, WI
- Department
- Legal
- Seniority
- Manager
- Education
- PhD
Description
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
- 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.
- Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions.
- Provide centralized regulatory support for manufacturing sites, including external partners, covering small molecules and biologics.
- Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations.
- Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale.
- 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.
- 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.
Preferred
- Advanced Degree (M.S., Ph.D., etc.) preferred.
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.