- Cardinal Health (Sacramento, CA)
- …Biotech and Medical Device/Medical Diagnostics with success + Experience selling consulting, drug development, regulatory services preferred + Highly organized + ... **Position Summary** For nearly five decades, Cardinal Health Regulatory Sciences' industry-trained regulatory consultants have provided expertise and guidance… more
- Stanford Health Care (Palo Alto, CA)
- …Clinic Administration, Clinic Managers and clinic staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug ... federal and state levels. + Knowledge of other relevant regulatory guidelines (eg, CMS, 340B, FDA ). +...other relevant regulatory guidelines (eg, CMS, 340B, FDA ). + Knowledge of theories, principles, practices and techniques… more
- Sumitomo Pharma (Sacramento, CA)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... proposed claims and assess consistency of proposed claims with FDA -approved labeling + Provide regulatory leadership to...experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs) + NDA… more
- BeOne Medicines (Emeryville, CA)
- …and standards are met. Externally, the individual will interface with outside regulatory agencies and more specifically, the FDA , and business partners ... regulatory requirements + Liaises and negotiates with the FDA and Health Canada as needed for all aspects...Health Canada as needed for all aspects pertaining to drug development including resolution of key regulatory … more
- Stanford University (Stanford, CA)
- …meet requirements of Stanford, Institutional Review Board (IRB), United States Food and Drug Administration ( FDA ), Office of Science Policy (OSP) and APB ... including project management in a dynamic research setting. + Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process,… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …products and drug -device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global … more
- Abbott (Santa Clara, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, international regulations and other regulatory ... communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA... regulatory standards including those set by the FDA or other worldwide regulatory agencies to… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory … more
- Cedars-Sinai (Los Angeles, CA)
- …Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary ... the gold standard of care we strive for. The Regulatory Coordinator II prepares and submits protocols and supporting...all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA or other health authority ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...JPMA, etc.). + Demonstrate solid working knowledge of the drug , biologic, and device development process, laws, regulations, and… more