Senior Manager, CMC Regulatory Affairs
Arrowhead Pharmaceuticals
August 21, 2026
Remote friendly (Verona, WI)
United States
$140,000 - $170,000 USD yearly
Corporate Functions
Responsibilities:
- Lead post-approval change management, including record evaluations and regulatory submissions (with possible strategic bundling), ensuring compliance with global requirements.
- Apply science- and risk-based approaches (ICH Q12) to assess and implement post-approval changes.
- Explore and implement automation/digital tools to increase efficiency and ensure repeatability in change control and submissions.
- Provide centralized regulatory support for manufacturing sites and external partners (small molecules and biologics).
- Collaborate with external sites/suppliers to align change control processes with global regulatory expectations.
- Evaluate and prioritize changes based on risk and scientific rationale to ensure site compliance.
- Align CMC teams with Global Regulatory CMC on post-approval strategy; represent Global Regulatory CMC in cross-functional Change Review meetings.
- Implement streamlined workflows to minimize delays and maximize impact.
Requirements:
- BS/BA in a scientific discipline.
- Experience with CMC Life Cycle Management systems (e.g., Veeva Registrations).
- 8+ years biopharma/device industry experience, including 5+ years direct Regulatory CMC experience (e.g., major variation/amendment leadership or support for initial NDA/BLA).
- Strong practical experience with global HA requirements.
- Understanding of scientific principles and global regulatory CMC requirements for drug development and post-market support.
- Proven ability to understand/communicate regulatory strategy to development, registration, and post-market support teams.
- Proven ability to develop global regulatory strategy recommendations using precedents and regulatory intelligence.
- Able to handle critical issues with minimal oversight; escalate and communicate issues/judgments appropriately.
Preferred:
- Advanced degree (M.S., Ph.D., etc.).
Compensation/Benefits:
- Wisconsin pay range: $140,000–$170,000.
- Competitive salaries and an excellent benefits package.
Application instructions:
- Must have current, valid authorization to work in the country where the role is located.
- Lead post-approval change management, including record evaluations and regulatory submissions (with possible strategic bundling), ensuring compliance with global requirements.
- Apply science- and risk-based approaches (ICH Q12) to assess and implement post-approval changes.
- Explore and implement automation/digital tools to increase efficiency and ensure repeatability in change control and submissions.
- Provide centralized regulatory support for manufacturing sites and external partners (small molecules and biologics).
- Collaborate with external sites/suppliers to align change control processes with global regulatory expectations.
- Evaluate and prioritize changes based on risk and scientific rationale to ensure site compliance.
- Align CMC teams with Global Regulatory CMC on post-approval strategy; represent Global Regulatory CMC in cross-functional Change Review meetings.
- Implement streamlined workflows to minimize delays and maximize impact.
Requirements:
- BS/BA in a scientific discipline.
- Experience with CMC Life Cycle Management systems (e.g., Veeva Registrations).
- 8+ years biopharma/device industry experience, including 5+ years direct Regulatory CMC experience (e.g., major variation/amendment leadership or support for initial NDA/BLA).
- Strong practical experience with global HA requirements.
- Understanding of scientific principles and global regulatory CMC requirements for drug development and post-market support.
- Proven ability to understand/communicate regulatory strategy to development, registration, and post-market support teams.
- Proven ability to develop global regulatory strategy recommendations using precedents and regulatory intelligence.
- Able to handle critical issues with minimal oversight; escalate and communicate issues/judgments appropriately.
Preferred:
- Advanced degree (M.S., Ph.D., etc.).
Compensation/Benefits:
- Wisconsin pay range: $140,000–$170,000.
- Competitive salaries and an excellent benefits package.
Application instructions:
- Must have current, valid authorization to work in the country where the role is located.