Associate Director, Regulatory Ops & Digital Enablement

Gilead Sciences Inc.; Foster City (CA); On-site; USD 182,000 - 236,000; Full time

Benefits offered by this job

Discretionary annual bonus

Stock‑based long-term incentives

Paid time off

Benefits package

Medical, dental, vision insurance

Job summary

Gilead Sciences Inc. is seeking an Associate Director of Regulatory Operations & Digital Enablement to advance operational effectiveness across CMC Regulatory Affairs and related functions.

The role partners with IT and process owners to design, implement, and optimize digital workflows that strengthen regulatory processes globally. You will lead cross-functional initiatives, drive data-driven decisions, and establish governance, standards, and KPIs while guiding change management and adoption

Qualifications

• 10+ Years with BS/BA
• 8+ Years with MS/MA or MBA
• Experience in regulatory operations, CMC Regulatory Affairs, pharmaceutical development or related regulated environment.
• Demonstrated experience leading business process design, mapping, optimization, or operational improvement initiatives.
• Experience translating business needs into requirements and partnering with technology teams to implement digital or system-enabled solutions.
• Experience leading complex, cross-functional initiatives in a global matrixed organization.

Responsibilities

• Lead complex cross-functional initiatives across CMC Regulatory Affairs and other functions.
• Identify pain points and opportunities for digital enablement in collaboration with process owners.
• Develop and monitor KPIs to evaluate process performance and adoption.
• Translate business needs into clear requirements for digital or AI-enabled solutions.
• Support change management and stakeholder engagement for new processes and tools.

Skills

Regulatory operations

Process improvement

Cross-functional leadership

Digital enablement

Data analytics

Regulatory affairs

Project leadership

Change management

Education

BS/BA in Life Sciences or Engineering

MS/MA or MBA

Tools

Veeva Vault

Planisware

Signavio

Visio

PowerBI

Job description

Gilead Sciences Inc. is seeking an Associate Director of Regulatory Operations & Digital Enablement to advance operational effectiveness across CMC Regulatory Affairs and related functions.

The role partners with IT and process owners to design, implement, and optimize digital workflows that strengthen regulatory processes globally. You will lead cross-functional initiatives, drive data-driven decisions, and establish governance, standards, and KPIs while guiding change management and adoption