CMC Compliance Lead for Global Clinical Manufacturing
University of California - San Francisco
University of California, San Francisco (UCSF) seeks a Senior Regulatory/CMC professional to provide strategic oversight of CMO activities for complex, multi-site trials. You will manage regulatory submissions, QC documentation, and ensure compliance with FDA/EMA guidelines across global operations. Responsibilities include leading cross-functional teams, overseeing timelines and budgets, and coordinating with Regulatory Affairs to address agency questions, ensuring quality and compliance in all #J-18808-Ljbffr University of California - San Francisco
- ...San Francisco, CA is hiring a Director, CMC Regulatory Affairs to lead regulatory strategies for CMC across... ...collaborate with regulatory, quality, clinical, and manufacturing teams to develop regulatory strategies and prepare global submissions. The role requires strong...Suggested
$211k - $264k
Overview Revolution Medicines is a late-stage clinical oncology company developing novel... ...The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation... ...across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and...SuggestedFull timeWork experience placementLocal area- Kardigan is seeking a Senior Director, CMC Regulatory to lead regulatory strategies and interactions for late-stage programs focused on cardiovascular... ...extensive experience with FDA, EMA, and ICH guidelines, plus a track record of successful global #J-18808-Ljbffr Socket.devSuggested
$244k - $305k
Revolution Medicines is a late-stage clinical oncology company developing novel targeted... ...: The Senior Director, Molecule Global Regulatory Lead will develop and execute global regulatory... ...Clinical Development, Biometrics, and CMC to deliver high-quality global submissions...SuggestedFull timeLocal area- A leading biotechnology company in South San Francisco seeks a Director of Clinical Regulatory to oversee multiple clinical drug candidates and drive development as a regulatory... ...project lead. The role involves overseeing global Health Authority interactions, leading...Suggested
- Anthropic is seeking a Partnerships Manager to advance clinical AI research on our global health initiatives, shaping how Claude is validated for use... ...robust evaluations and product improvements. You will also lead cross‑functional partnerships with regulators, ethics...
- Zai Lab Limited in the United States, headquartered in Cambridge, MA, seeks a Senior Clinical Trial Manager to lead global trial operations from start-up to close-out in compliance with ICH-GCP and local regulations. You will coordinate cross-functional teams across timelines...Local area
- Meyer Sound in Berkeley, CA is seeking a Regulatory Compliance Manager to coordinate safety, environmental, regulatory, and market... ...across new product development, sustaining engineering, manufacturing, and global certification programs. Reporting to the Director of...
$240.94k - $291.96k
...Expected Areas of Competence Develop and lead Global and US Regulatory activities for a... ...documents and study reports, including Clinical protocols, clinical reports/summary documents... ...State* California Job_Category Manufacturing Job Code Pharmaceutical Pharmaceutical...Local area$220k - $270k
...Pharmaceuticals is seeking a Senior Director/Director of CMC Regulatory Affairs to lead CMC regulatory activities in South San Francisco. The ideal... ...collaboration across various departments to ensure compliance with CMC regulatory strategies for oncology products. The...$204k - $281k
About This Role:As the CMC Asset Lead, you will be an integral part of the PO&T Nephrology team... ...be on overseeing a critical asset in clinical development for multiple indications, including... ...in alliance management, preferably global, and understanding of business...Full timeTemporary workLocal area$200k - $300k
...unified payments and financial platform for global businesses. Powered by our unique... ...Valued at US$11 billion and backed by world-leading investors including T. Rowe Price, Visa,... ...& Operations and other Legal, Risk and Compliance teams across Airwallex. Our mandate is to...Temporary workLocal areaWorldwide- Structure Therapeutics is seeking a highly motivated Sr. Clinical Trial Manager to oversee day-to-day global trials. You will manage internal stakeholders, CROs, and vendors, ensuring studies run on time and within budget across multinational sites in a late-stage program...
$261k - $304.5k
Cytokinetics is seeking a Senior Director, CMC Lead to drive CMC product development for their pipeline. This role will be responsible for product development strategy across clinical life-cycles, leading cross-functional teams with a focus on drug substance, drug product...- ...Affairs in South San Francisco, CA to lead regulatory strategy and execution for clinical programs across regions. This... ...authority interactions, ensuring compliance and timely deliverables. The... ...development documents, and monitor global regulatory developments while maintaining...
- Senti Biosciences seeks a senior regulatory leader to own and drive CMC regulatory strategies for a complex cell therapy portfolio. You will coordinate global submissions, interact with agencies, and guide cross-functional teams in a fast-paced environment in South San...
- ...seeking an Immigration Program Manager to support growing immigration and global mobility programs. You will be a primary contact for visa-sponsored Figmates, managing immigration cases, compliance, and employee experience. You’ll also support international relocations...Full timeRemote workRelocationVisa sponsorship
- Anthropic is seeking a Global Senior Equity Program Manager to lead the equity compensation strategy across all markets. This role involves designing and... ...will oversee equity plan operations, ensure compliance, and provide support to employees on equity-related matters...
- Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life‑threatening... ...promising development pipeline. Overview The Global Clinical Trial Leader (CTL) is accountable for the...Local areaFlexible hours
- ...Immigration Program Manager to support its growing Immigration and Global Mobility programs. You will serve as a primary contact for visa-sponsored Figmates, manage immigration cases, and ensure compliance while supporting relocations and global mobility initiatives. In...Remote jobRelocationVisa sponsorship
$78.9k - $131.5k
...com addresses. Why This Role Matters As Rippling expands its global footprint, launching seamless payroll and expense products around... ...you won't just file paperwork, you'll serve as a core legal & compliance partner, helping us navigate complex international regulatory...Local area- Mondo is seeking a People Ops Automation & Compliance Manager to partner with People Operations and cross-functional teams. The role leads automation, compliance, and project delivery across global HR operations, enabling scalable and AI-enabled solutions. The position...
$185k - $200k
A leading oncology company in San Francisco seeks an experienced Associate Director, Clinical Supply Chain. This role requires over 10 years of experience in clinical supply chain management, overseeing global inventories, and developing IRT systems. The successful candidate...- Sierra in San Francisco is on the lookout for a Payroll Manager to take ownership of global payroll operations. You will ensure accuracy and compliance while designing scalable systems that support corporate growth. Your role will involve managing payroll across various...
- GQR seeks a Senior Manager, Clinical Supplies Planning & Logistics to lead global IP forecasting, packaging, labeling, and distribution for Phase I-III studies. You will build study-level demand plans and manage CMOs, depots, and logistics vendors, while designing packaging...Worldwide
- ...develop strategies, manage submissions, and coordinate with distributors and consultants to navigate global markets. You will collaborate with Quality, R&D, Manufacturing, and Commercial Sales to ensure timely registrations and responsiveness to market changes. #J-18808...
- ...across R&D, new-product introduction, manufacturing, and third-party custody models, we... ...About the Role We are hiring an Asset Compliance Program Lead to establish the cross-business framework... ...manufacturing equipment or tooling, global custody, logistics, or physical...Contract work
- Thunes is seeking an Americas-based Compliance professional to lead and support the US regulatory program. The role partners with Global Compliance, Financial Crime, KYC, and Risk teams, reporting to the Americas Compliance Director in Miami. The position is office-based...Work at office
- ...seeking an Associate Director, GMP Quality to oversee GMP activities for clinical and commercial products, including review of batch records and supplier compliance. The role requires collaboration with CMC, Regulatory, and Supply Chain functions and may involve visits to...
- ...Director, Supply Chain Operations to lead global product planning, procurement,... ...availability, regulatory compliance, and inventory optimization using... .../week, collaboration across Clinical, Commercial, Development, Finance, Manufacturing, Quality, Regulatory, and IT, and...
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