Senior Director, Regulatory Data & Content Strategy (CMC)

Regulatory Jobs; Foster City (CA); Sur place; USD 243 000 - 315 000; Plein temps

Résumé du poste

Gilead is seeking a Senior Director, Regulatory Data & Content to lead the data domain for CMC Regulatory Affairs. You will define governance, standards, and capabilities to manage regulatory data as enterprise assets, ensuring they are trusted, interoperable, and ready for advanced analytics and AI-enabled regulatory interactions.

You will collaborate with Digital Enablement, Regulatory Operations, Portfolio Insights & Analytics, IT and other functions to align data definitions, metadata, and

Qualifications

• Bachelor's Degree and 14 years’ experience OR Masters' Degree and 12 years’ experience OR PhD and 12 years’ experience.
• Extensive pharmaceutical/biotech experience in Regulatory Affairs, regulatory operations, data management or related functions.
• Leadership of enterprise data domains with governance, standards, stewardship and data quality.
• Strong understanding of CMC Regulatory Affairs, regulatory lifecycle and related standards (ISO IDMP, SPOR, eCTD).

Responsabilités

• Lead Regulatory Data Strategy, Governance & Domain Leadership for CMC Regulatory Affairs.
• Establish and lead data governance model with ownership, decision rights, stewardship, quality standards.
• Represent CMC Regulatory Affairs in PDM and enterprise governance, negotiating standards and commitments.
• Partner with Clinical Regulatory Affairs to align data definitions, standards and information models.
• Shape evolution of regulatory data/content management for analytics, automation, and AI-enabled capabilities.
• Build integrated operating model with Digital Enablement, Regulatory Operations & Analytics.

Connaissances

Regulatory data governance

Data strategy leadership

Cross-functional collaboration

AI/Analytics readiness

Regulatory information management

Leadership

Formation

Bachelor's Degree

Master's Degree

PhD

Advanced degree in science field

Outils

Veeva Vault RIM

RIM platforms

Content management systems

Description du poste

Gilead is seeking a Senior Director, Regulatory Data & Content to lead the data domain for CMC Regulatory Affairs. You will define governance, standards, and capabilities to manage regulatory data as enterprise assets, ensuring they are trusted, interoperable, and ready for advanced analytics and AI-enabled regulatory interactions.

You will collaborate with Digital Enablement, Regulatory Operations, Portfolio Insights & Analytics, IT and other functions to align data definitions, metadata, and