This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based counterpart and global cross-functional stakeholders in the development and execution of global CMC regulatory strategies across the product lifecycle
Job Summary
This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based counterpart and global cross-functional stakeholders in the development and execution of global CMC regulatory strategies across the product lifecycle.
The position manages a U.S.-based team of approximately 15 reports and reports to the Global Head of Regulatory CMC.
The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
Matching Summary
This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based counterpart and global cross-functional stakeholders in the development and execution of global CMC regulatory strategies across the product lifecycle.
Salary
Base: $204,500.00 - $274,500.00 annually; Bonus/Equity: Eligible for annual bonus plan and equity awards; Benefits: Comprehensive benefits package
Skills & Requirements
Must-have
Biologics Regulatory CMC strategy
Health Authority interactions
CTD Modules 2 and 3 authoring
Global regulatory expectations
Product lifecycle management
Nice-to-have
Collaborative and passionate interest
Scientific and business professionals
Continuous process optimization
External forums and industry groups
Key Requirements
12+ years pharmaceutical/biopharmaceutical experience