Director, CMC Regulatory Affairs – Devices & Combo Products

Regulatory Jobs; Foster City (CA); Vor Ort; USD 210.000 - 272.000; Vollzeit

Benefits dieser Stelle

Discretionary annual bonus

Stock-based long-term incentives

Benefits package including medical, Rx

Paid time off

Zusammenfassung

Gilead Sciences, Inc. seeks a Director, CMC Regulatory Affairs - Combination Products and Device to set the global CMC regulatory strategy for complex device and combination product programs.

You will partner with PDM, Global Regulatory Affairs, Quality and other functions to shape development, lifecycle strategy, and regulatory risk management. You will lead global submissions, advise on health authority interactions, and guide cross-functional teams through evolving regulatory landscapes to

Qualifikationen

• 12+ years with BA/ BS
• 10+ years with MA/ MS/ MBA
• 8+ years with PharmD/ PhD
• Significant experience defining and leading regulatory strategies for complex products
• Deep knowledge of global regulatory requirements for devices and combination products
• Demonstrated success influencing strategy across senior cross-functional stakeholders
• Strong experience engaging with health authorities and shaping regulatory approaches

Aufgaben

• Set and lead global CMC regulatory strategy for complex device and combination product portfolios
• Shape regulatory approaches supporting product development, registration, lifecycle management
• Partner with cross-functional teams to influence development, manufacturing and control strategies
• Lead resolution of regulatory issues where precedents are limited
• Guide risk mitigation and contingency planning across major programs
• Oversee global submissions, post-approval changes, and other major milestones
• Represent CMC Regulatory Affairs in health authority interactions on CMC topics
• Drive consistent interpretation of global regulations for devices and combination products
• Bridge global, regional, and functional stakeholders for alignment and execution
• Contribute to strategic capability development and external industry engagement

Kenntnisse

CMC regulatory strategy

Global regulatory affairs

Devices regulation

Combination products

Ausbildung

BA/BS

MA/MS/MBA

PharmD/PhD

Jobbeschreibung

Gilead Sciences, Inc. seeks a Director, CMC Regulatory Affairs - Combination Products and Device to set the global CMC regulatory strategy for complex device and combination product programs.

You will partner with PDM, Global Regulatory Affairs, Quality and other functions to shape development, lifecycle strategy, and regulatory risk management. You will lead global submissions, advise on health authority interactions, and guide cross-functional teams through evolving regulatory landscapes to