Director, Regulatory Affairs Data Governance Lead

$205,700 - $266,200/Yr

Gilead Sciences - Foster City, CA

Full-time

Foster City, CA

Chemical Manufacturing

About the position

The Data Governance Lead for Regulatory Affairs will be responsible for defining, implementing, and overseeing data governance strategies and frameworks within the regulatory affairs domain. Regulatory information assets are a core asset for regulatory affairs and the broader enterprise at Gilead, this leader will ensure data integrity and quality expectations are embedded into the ways of working within the organization. This role ensures compliance with global regulatory data requirements, drives data quality initiatives, and facilitates alignment between global regulatory affairs and cross-functional teams. The role will provide strategic input and operational leadership for data domain teams that will focus on data quality throughout the regulatory affairs organization. The incumbent will collaborate with patient safety, quality, regulatory CMC, commercial, clinical, and other development organizations on data governance activities that interfaces with end-to-end regulatory processes. The role will align and leverage broader master data management initiatives that exist within the development systems and information technology organizations. The role will lead efforts to improving our data quality through establishing authoritative datasets and leveraging innovative technologies.

Responsibilities

• Leads the Regulatory Affairs Data Governance Council and drives the overall approach for data integrity and quality for the organization.
• Designs and implement a comprehensive data governance framework that is fit for purpose for Regulatory Affairs data and processes.
• Accountable for driving an effective and integrated cross functional data governance that crosses organizational boundaries.
• Leads a matrixed team of representatives from the data domains across the organization.
• Define data standards, policies, and procedures to ensure consistency, accuracy, and compliance across the organization.
• Act as the custodian for regulatory data, ensuring data quality, completeness, and reliability.
• Ensure all regulatory data adheres to local, regional, and global compliance requirements, including FDA, EMA, and other regulatory bodies.
• Partner with quality and compliance teams to stay updated on evolving regulatory standards and inspection readiness expectations, integrate needs into data quality practices.
• Collaborate across Regulatory Affairs functions and Quality to establish authoritative datasets, data governance priorities and objectives.
• Provide guidance to functions on data governance and stewardship best practices for their organization.
• Evaluate and implement data quality management tools and technologies to improve business operations and data quality.
• Drives digital innovation across the data governance activities and approaches.
• Collaborate with development systems and data owners to manage system upgrades, integrations, and enhancements related to regulatory data integrity and quality.
• Develop and track key performance indicators (KPIs) to measure the effectiveness of data governance initiatives.
• Generate reports for senior management and functional leadership as needed on state of regulatory data.

Requirements

• MA/MS/MBA/PharmD/PhD with 10+ years' relevant experience.
• BA/BS in Life Sciences, Information Management, Regulatory Affairs, or related field with 12+ years' relevant experience.
• 10+ years' experience in life sciences/biotech industry. Extensive experience leading data governance and stewardship capabilities in a regulated environment.
• Strong experience in the domains of regulatory information and how they relate to the product development and lifecycle management activities of our portfolio.
• Extensive experience and significant successes establishing authoritative data assets and developing operating constructs to ensure data integrity and quality.
• Strong track record of successes working and negotiating across organizations in a matrixed environment.
• Experience in leading high-complexity, large-scale, cross-functional global initiatives in regulatory affairs.
• Certifications in PMP, change management, or Six Sigma/Lean are a plus.
• Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.

Nice-to-haves

• Strong knowledge of the biopharma industry, including in-depth understanding of regulatory affairs and adjacent business functions.
• In-depth knowledge of systems, tools, metrics, and digital technologies to support regulatory affairs and broader data governance.
• Strong understanding of global regulatory requirements (e.g., FDA, EMA, ICH).
• Knowledge of data privacy regulations (e.g., GDPR, HIPAA) and their implications for regulatory data management.
• Demonstrates ability to rapidly become acquainted with Gilead's current ways of working and data quality approaches.
• Demonstrates advanced regulatory and business knowledge and advanced analytical abilities.
• Proven ability to influence up, down, and across the organization and externally in a collaborative manner.
• Strong communication and organizational skills.
• Advanced meeting facilitation, organizational, and communication skills.
• Strong negotiation and conflict resolution skills.

Benefits

• Discretionary annual bonus
• Discretionary stock-based long-term incentives
• Paid time off
• Company-sponsored medical, dental, vision, and life insurance plans