Senior Manager, CMC Regulatory Affairs

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.

Pay

Wisconsin pay range: $140,000 USD - $170,000 USD

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.