- Sumitomo Pharma (Sacramento, CA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- BeOne Medicines (San Mateo, CA)
- …in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems ... for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders + Provides regional input on global study… more
- Cedars-Sinai (Beverly Hills, CA)
- …standards by monitoring all ongoing activities and interacting regularly with QA and Regulatory Affairs . + Leads projects, trains, and assists in day-to-day lab ... to field development through effective project management and compliance with regulatory and safety standards. **Primary Duties and Responsibilities:** + Supervises… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Partner across Kite Medical Affairs , Clinical Development, Translational Medicine, Regulatory Affairs , and Product Teams to build integrated cross-functional ... assets in collaboration with the entire Evidence Generation Function, Global Medical Affairs Strategy and Product Teams. + Provide leadership to support the… more
- ThermoFisher Scientific (Carlsbad, CA)
- …**Experience** + Minimum 5 years regulatory experience in product stewardship / regulatory affairs / compliance / chemical consultancy / risk assessment + ... in-depth and operational understanding of chemical regulations, experience working with regulatory agencies, and thrive on working with diverse challenges. If this… more
- The Clorox Company (Pleasanton, CA)
- …Daily cross-functional collaboration is essential, involving teams across Product Safety & Regulatory Affairs (PS& RA ), Product Development, Legal, Corporate ... Quality, Marketing, and Government Affairs . Through this work, you will play a key... Strategy & Project Leadership** + Independently represent the PS& RA function on cross-functional project teams, ensuring regulatory… more
- FocusKPI Inc. (Mountain View, CA)
- …+ Meeting with key stakeholders (PM, Head of User Experience and Human Factors, Regulatory Affairs , Head of Engineering) to understand key milestones for product ... development. + Working with recruiting vendors to recruit participants for a study (includes writing a screener, securing budget approval, and communicating with the recruiting vendor leading up to the study). + Writing study plans that use appropriate methods… more
- Envista Holdings Corporation (Brea, CA)
- …launches, events, dealer support, and asset development. + Collaborates with Legal, and Regulatory Affairs as well as Key Opinion Leaders, Product Management, ... R&D, and Sales in the creation and approval of marketing and sales assets. + Maintain and manage all marketing assets in the document control system (Master Control) and well as sales enablement tools and or SharePoint. + Manage the events process and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …stakeholders to establish strong working relationships with quality groups, colleagues in Regulatory Affairs , Global Trade Ops, Global Commercial Operations & ... & cluster (group of countries) QA leads with interpreting the local & regional regulatory requirements as they pertain to the distribution of Gilead products + Act… more
- Abbott (Pleasanton, CA)
- …information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. + Medical device industry experience. + ... with US Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.… more