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Head of CMC Regulatory Affairs – Strategy and Operations

Head of CMC Regulatory Affairs – Strategy and Operations

Gilead Sciences, Inc.Foster City, CA, United States
1 day ago
Job type
  • Full-time
Job description
  • Oversee digital modernization of core CMC RA platforms (e.g., RIM) and integration across systems.
  • Stand up for CMC RA (with enterprise thinking) and oversee a digital / AI fluency and enablement team aligned to strategic priorities.
  • Create guidelines, systems, and processes for CMC RA knowledge management, in alignment and partnership with any broader initiatives in this space across the enterprise.
  • Lead workforce capability design, training strategy, and upskilling initiatives.
  • Domain Knowledge & Experience
  • Requires a PhD or MS with 14+ years of relevant professional experience, or BS with 16+ years of relevant professional experience – a degree in chemistry or a related scientific discipline is strongly preferred.
  • Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives.
  • Experience with CMC requirements for drug development of a range of product modalities.
  • Comprehensive understanding of the biopharmaceutical industry, R&D, and product commercialization, including the regulatory framework.
  • Experience designing, selecting, and implementing digital tools such as RIM, structured content authoring, LIMS, or GenAI applications with an enterprise mindset.
  • Understanding of structured content, automation, and enterprise knowledge systems.
  • Strategic thinking and ability to influence and constructively challenge the status quo.
  • Strong business acumen.
  • Ability to blend strategic acumen, regulatory fluency, and operational rigor with a strong background in change leadership, data governance, and digital transformation.
  • Experience in managing organizational cross-functional initiatives and / or business operations programs.
  • Ability to design and optimize organizations.
  • Excellent organizational and communication (both written and verbal) skills with all levels of an organization.
  • Ability to work and influence within a matrixed environment and regularly collaborate with cross-functional teams across Technical, Research, and Development.
  • Ability to manage multiple priorities, to draw out diverse views, and to show tact and discretion in challenging situations.

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    Head Of Regulatory • Foster City, CA, United States

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