- Amgen (Thousand Oaks, CA)
- …improvements, and support method and validation and transfers + Contribute to global regulatory filings by authoring analytical CMC sections and RTQs ... management activities. The role will involve close partnership with local and global Quality and will also involve representation of Attribute Sciences on … more
- Parexel (Sacramento, CA)
- … drug safety regulations and guidelines + Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure ... while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance. **About the Role** As a **Senior Physician in Patient… more
- Oracle (Sacramento, CA)
- …software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based ... for regulated medical devices. This role bridges product development, regulatory , and enterprise architecture functions-ensuring that device software solutions are… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …approaches. + Ensure training content is accurate, current, and aligned with global regulatory requirements (FDA, EMA, ICH). **Compliance & Risk Management** ... senior leader within the Learning Center of Excellence under Global Quality. This role is responsible for developing and...global GxP training strategy to ensure compliance with regulatory requirements and foster a strong quality culture across… more
- LinkedIn (Mountain View, CA)
- …security into products and engineering systems. The role will focus on various global regulatory frameworks and certifications. Primary focus will be the full ... network, built to create economic opportunity for every member of the global workforce. Our products help people make powerful connections, discover exciting… more
- Bristol Myers Squibb (San Diego, CA)
- …manufacturing, quality, supply chain, and commercial functions. + Advise on global regulatory matters relevant to radiopharmaceuticals, including FDA regulations ... supply, manufacturing, licensing, collaboration, and research agreements. + Monitor evolving global legal, regulatory , and enforcement developments relevant to… more
- ThermoFisher Scientific (Carlsbad, CA)
- …Day in the Life:** + Interpret and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical ... regulatory expertise and support to business leadership. + Develop regulatory strategies accounting for global requirements and desired marketing claims.… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory /legal requirements, establishing governance frameworks to ensure ... Collaborate with the CNS Medical BU Lead and cross-functional teams (eg, Global Integrated Evidence & Innovation, Clinical Development, Regulatory , Commercial)… more
- Genentech (South San Francisco, CA)
- …regulated healthcare or life sciences environments + You have strong working knowledge of global regulatory frameworks (eg, HIPAA, GDPR, GxP, FDA, EMA) and their ... health, AI/ML, and data science domains, ensuring alignment with regulatory requirements and Roche global standards +...ensuring alignment with regulatory requirements and Roche global standards + You translate evolving global … more
- AbbVie (Irvine, CA)
- …fostering a culture of proactive risk identification, mitigation, and compliance with global regulatory and industry standards. Additionally, they will lead the ... Operations, Pharmacovigilance, pre-Clinical, or Manufacturing. + Deep knowledge of global regulatory frameworks, inspection readiness, compliance standards, and… more