Head of CMC Regulatory Affairs – Strategy and Operations

Role Summary

Head of CMC Regulatory Affairs – Strategy and Operations leads the CMC RA function's strategic direction, capability building, and cross-functional operations to enable regulatory excellence and digital modernization across programs. The role focuses on developing innovative roadmaps, improving operating models, and aligning process and data strategies with enterprise objectives. It requires strong leadership, strategic thinking, and the ability to drive cross-functional initiatives in a matrixed environment.

Responsibilities

• Develop a roadmap that fosters innovation to assist where and when CMC RA invest resources and budget.
• Own continuous improvement of the operating model and capability roadmap for the CMC RA function.
• Creating and implementing functional business strategies
• Improving performance and operational excellence
• Centralizing key activities to support each team’s global product, pipeline, and people’s ambitions
• Design, build, and lead a high-performing organization to drive strategic initiatives, centralize activities, and foster cross-functional support of CMC RA’s processes, systems, data, and tools.
• Define and track Key Performance Indicators for CMC RA.
• Collaborate with other functions to ensure that CMC RA systems are operating seamlessly connected with the broader enterprise.
• Partner with Regulatory Affairs, Quality, Technical Development, and Manufacturing stakeholders to align process and digital/data modernization strategies.
• Support centralized resource management for CMC RA resources defined in Gilead’s resource forecasting system (i.e., Planisware).
• Manage CMC RA Operational Excellence activities with a goal of identifying synergies and efficiency across all CMC RA functions to reduce overall spending (responsible for leading the CMCRA leadership thought LRP, budget, etc.).
• Manage cross functional teams, internal teams, and complex project teams (NPPs, RA / CMCRA teams, complex programs, etc.)
• 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.

Qualifications

• 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.

Skills

• Digital fluency and enterprise-wide knowledge management
• Regulatory operations, strategic planning, and program management
• Cross-functional leadership and stakeholder collaboration
• Data governance, process optimization, and change leadership
• Analytical mindset with the ability to define and track KPIs