- Merck (San Francisco, CA)
- …coaching/guidance to individual contributors + Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics and ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an...authoring regulatory documents (INDs, CSRs, CTDs) **Required Experience:** + (a… more
- Medtronic (Irvine, CA)
- …to relevant industry standards and compliance regulations (eg ISO 13485 and global regulatory requirements). **Must Have: Minimum Requirements** _To be ... differently to solve problems, make progress, and deliver meaningful innovations. Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality… more
- Ascendis Pharma (Palo Alto, CA)
- …validated Drug Safety Databases (Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Expert knowledge of FDA ... safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global ...applicable regulatory guidance documents; working knowledge of global safety regulations. + Ability to travel up to… more
- Google (Mountain View, CA)
- …requirements, enhancing controls, increasing data processing frequency, and ensuring global regulatory compliance. You will drive programmatic transformation ... Lead Google's corporate environmental metrics accounting program, ensuring compliance with global regulatory , voluntary, and internal disclosure requirements. +… more
- BeOne Medicines (Emeryville, CA)
- …success initiating change and influencing at all levels + Understands comprehensive global pharmaceutical regulatory requirements (eg GMP, GDP) + Strong ... The position is responsible for a managing all aspects of global Contract Manufacturing partnerships, driving productivity through strategic initiatives with… more
- BeOne Medicines (San Mateo, CA)
- …CMC, Regulatory , etc.) stakeholders. + Demonstrates advanced knowledge of global clinical trials and the drug development process. + Experience in vendor ... of IRT system functionality and Excel modeling. + Understands comprehensive global pharmaceutical regulatory requirements (eg cGMP, ICH/GDP, GCP, 21… more
- Amgen (Thousand Oaks, CA)
- …+ Experience in cGMP manufacturing environment, knowledge of cGMP's and other global regulatory requirements. + Demonstrated ability in leading multi-functional ... of its customers and applicable regulations (FDA, EU & global standards). + Assist in the development of any...the necessary regulations. + Be a key contributor to regulatory filings throughout the authoring, editing and submission process… more
- Coinbase (Sacramento, CA)
- …Familiarity with privacy laws specific to financial institutions (eg GLBA) and the global financial regulatory frameworks (eg AML/KYC compliance, PSD2). * CIPP ... emerging onchain platform - and with it, the future global financial system. To achieve our mission, we're seeking...and Trust & Risk to respond to privacy incidents, regulatory inquiries, law enforcement demands, and other information requests.… more
- Merck (South San Francisco, CA)
- …reporting and interpretation of data. + Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory ... external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and… more
- Adecco US, Inc. (Los Angeles, CA)
- …or compliance (GMP for cosmetics) + Familiarity with cross-border operations and global supply chain regulatory challenges **About the job** **Location:** Los ... play a critical part in bridging communication with our global headquarters, overseeing product compliance, import documentation, product quality-related customer… more