Global regulatory strategies for combination products
Lead global cmc regulatory initiatives
Enterprise collaboration and influence
Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and regulatory expectations
Job Summary
Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and regulatory expectations.
Cultivate strong, collaborative relationships across Gilead’s global functions, including Quality, Manufacturing, Technical Development, Clinical Development, and Supply Chain.
Foster a culture of integrity, excellence, and continuous improvement within the global CMC RA organization.
Matching Summary
Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and regulatory expectations.
Salary
$274,550.00 - $355,300.00; Bonus/Equity: Discretionary annual bonus, discretionary stock-based long-term incentives; Benefits: Medical, dental, vision, and life insurance plans
Skills & Requirements
Must-have
Global regulatory strategies for combination products
Lead global CMC regulatory initiatives
Enterprise collaboration and influence
Oversight for late-stage development programs
Design Control and Technical Strategy input
Nice-to-have
Champion regulatory innovation
Foster a culture of integrity and excellence
Drive innovation and influence organizational change
Key Requirements
16+ years with BA/BS or 14+ years with MA/MS, PhD, PharmD, or MD
Experience leading NDA/BLA submission and approvals
Experience supporting IND/IDE and NDA/BLA filings
In-depth understanding of ICH guidelines and GMP requirements
Proven track record in commercialization of device technologies