Director, Regulatory Data & Content Strategy (CMC)

Biopharma Asia; Foster City (CA); On-site; USD 243,000 - 315,000; Full time

Benefits offered by this job

Discretionary bonus

Stock-based long-term incentives

Paid time off

Benefits package

Job summary

Gilead Sciences is seeking a Senior Director, Regulatory Data & Content to lead the data domain for CMC Regulatory Affairs, defining strategy, governance, standards, and capabilities to manage regulatory data and content as critical enterprise assets.

The role oversees data definitions, master data management, stewardship, and governance, with enterprise influence across PDM-level initiatives and cross-functional teams.

Qualifications

• Bachelor's Degree and 14 years’ experience OR
• Masters' Degree and 12 years’ experience OR
• PhD and 12 years’ experience

Responsibilities

• Serve as the data domain leader for CMC Regulatory Affairs, accountable for regulatory data strategy, definitions, standards, governance, quality, and stewardship.
• Lead the CMC Regulatory Affairs data governance model with ownership, decision rights, stewardship, and quality standards.
• Represent CMC Regulatory Affairs in PDM and enterprise data governance committees; establish regulatory positions and standards.
• Partner with Clinical Regulatory Affairs and other functions to align data definitions and information models.
• Define and advance content management strategy and standards across the regulatory lifecycle; enable traceability and reuse of regulatory information.
• Establish AI-ready regulatory data foundations with metadata, provenance, traceability, and interoperability.

Skills

Leadership

Regulatory affairs

Data governance

Education

Bachelor's Degree + 14 yrs exp

Master's Degree + 12 yrs exp

PhD + 12 yrs exp

Tools

Veeva Vault RIM

Regulatory data platforms

Job description

Gilead Sciences is seeking a Senior Director, Regulatory Data & Content to lead the data domain for CMC Regulatory Affairs, defining strategy, governance, standards, and capabilities to manage regulatory data and content as critical enterprise assets.

The role oversees data definitions, master data management, stewardship, and governance, with enterprise influence across PDM-level initiatives and cross-functional teams.