Gilead Sciences · 10 hours ago
Head of CMC Regulatory Affairs – Strategy and Operations
San Francisco Bay Area
Full-time
Onsite
Director/Executive
$302K/yr - $391K/yr
14+ years expGilead Sciences is dedicated to creating a healthier world for all people, focusing on tackling major diseases and improving lives through innovative therapies. The Head of CMC Regulatory Affairs – Strategy and Operations will develop strategies for continuous improvement, lead cross-functional teams, and oversee digital modernization efforts within the CMC RA function.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
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
Qualification
Required
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
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2025-12-30
BioWorld Financial Watch
2025-12-29
Company data provided by crunchbase