- Gilead Sciences, Inc. (Foster City, CA)
- …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 (ie, Planisware). + Manage CMC RA Operational Excellence activities with a goal of identifying synergies… more
- Abbott (Alameda, CA)
- …working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. . Experience with 510(k) applications, PMA ... supplements, US device regulations, and/ or with EU and other international medical device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, clinical investigations, ICH… more
- AbbVie (Irvine, CA)
- …. Job Description The Strategic Global Labeling Manager in Regulatory Affairs is responsible for developing and delivering patient-centered global product labeling ... for the safe and effective use of AbbVie products. The key responsibilities include leading cross-functional teams to develop comprehensive label strategies and create accurate labeling for development and marketed products, ensuring compliance with company… more
- Veterans Affairs, Veterans Health Administration (Mather, CA)
- …seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). You may be required to serve a ... of the schools approved by the Department of Veterans Affairs for the year in which the course of...completed residency training, approved by the Secretary of Veterans Affairs in an accredited core specialty training program leading… more
- Veterans Affairs, Veterans Health Administration (Fresno, CA)
- …seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). You may be required to serve a ... of the schools approved by the Department of Veterans Affairs for the year in which the course of...completed residency training, approved by the Secretary of Veterans Affairs in an accredited core specialty training program leading… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …in cross-functional collaboration** : Attend and contribute to meetings with Regulatory Affairs , Commercial, and other departments to gain insight into the broader ... drug development and lifecycle management processes. + Showcase your work with a final presentation (PPT) near the conclusion of your internship **Required Qualifications:** + Must be at least 18 years old + Must have a minimum GPA of 2.8 + Authorized to work… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Engage in cross-functional collaboration with Development, International Regulatory Affairs , and other stakeholders to understand research priorities. + Conduct ... background research on FDA, EMA, and ICH guidelines, or other relevant data to support Gilead's non-cell therapy oncology pipeline. + Identify areas where regulatory guidance may lack clarity, be outdated, or where new references are anticipated. + Contribute… more
- ThermoFisher Scientific (Carlsbad, CA)
- …find cures for cancer. **Discover Impactful Work** As a Sr. Manager, Regulatory Affairs , you will play a crucial role in interpreting and disseminating global ... regulations, guidelines, and emerging industry developments that directly influence our business in pharmaceutical product development. Applying your expertise, you will actively contribute to continuously developing and aligning our regulatory tools,… more
- Edwards Lifesciences (Irvine, CA)
- …to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and ... international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians… more
- Veterans Affairs, Veterans Health Administration (Mather, CA)
- …seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). You may be required to serve a ... of the schools approved by the Department of Veterans Affairs for the year in which the course of...completed residency training, approved by the Secretary of Veterans Affairs in an accredited core specialty training program leading… more