Regulatory Data & Content Manager (CMC)

Regulatory Jobs

Foster City (CA)

On-site

USD 147,000 - 190,000

Full time

3 days ago
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Job summary

Gilead is seeking a Manager, Regulatory Data & Content, CMC Regulatory Affairs to oversee regulatory data quality, governance, and content management across the CMC lifecycle. You will steward data, improve processes, and collaborate with digital enablement, regulatory operations, and analytics teams.

The role focuses on maintaining data integrity, enabling data-driven decisions, and shaping governance in a fast-paced biopharma environment.

Qualifications

  • 6+ years of experience with BS/BA or 4+ years with MS/MA in relevant fields.
  • Experience in pharmaceutical/biotechnology Regulatory Affairs or data management.
  • Experience with Veeva Vault or regulatory information management systems.
  • Strong analytical and problem-solving skills; attention to data accuracy and quality.
  • Ability to perform operational data stewardship and maintenance while developing broader governance expertise.

Responsibilities

  • Serve as an operational data steward for CMC Regulatory Affairs, maintaining regulatory data in systems.
  • Support data governance, data definitions, standards, and quality expectations.
  • Participate in data governance forums and bring requirements back to CMC Regulatory Affairs.
  • Contribute to process, content enablement and documentation of workflows and rules.
  • Partner with cross-functional teams to improve data flows and analytics.

Skills

Regulatory data governance
Data quality
Veeva Vault
Cross-functional collaboration
Attention to detail

Education

BS/BA in Life Sciences or related field
MS/MA in relevant field

Tools

Veeva Vault
Regulatory information management systems

Job description

Gilead is seeking a Manager, Regulatory Data & Content, CMC Regulatory Affairs to oversee regulatory data quality, governance, and content management across the CMC lifecycle. You will steward data, improve processes, and collaborate with digital enablement, regulatory operations, and analytics teams.

The role focuses on maintaining data integrity, enabling data-driven decisions, and shaping governance in a fast-paced biopharma environment.

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