- Cardinal Health (Sacramento, CA)
- …research, industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions ... knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct...Support research to maintain a pulse on product, supplier, regulatory , and market dynamics; understand how industry trends may… more
- Stanford Health Care (Palo Alto, CA)
- …front-line staff, clinic managers, nurse managers, etc.) on medication-related issues such as regulatory changes/compliance, FDA drug recalls, drug ... Clinic Managers and clinic staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, special programs,… more
- Abbott (Santa Clara, CA)
- …of medical device regulations and experience such as from the Food and Drug Administration ( FDA ) Center for Devices and Radiological Health (CDRH). This ... + Communicates with internal groups to share updates on regulatory changes as it pertains to the FDA + Utilizes technical regulatory skills to proposed… more
- Abbott (Santa Clara, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, ... product market entry. **What You'll Work On** + Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve… more
- Abbott (Alameda, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, ... approval requirements as needed. **Core Responsibilities** + Prepares robust regulatory applications (either for FDA or for...+ Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Diploma/GED and 14+ years of relevant industry experience Preferred Qualifications: + Regulatory review of promotional materials for prescription drug and/or ... desirable. + An advanced degree is also desirable. + Experience working with FDA 's Office of Prescription Drug Promotion or Advertising and Promotional Labeling… more
- Sumitomo Pharma (Sacramento, CA)
- …a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, guidance ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … 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
- Kelly Services (Petaluma, CA)
- ** Regulatory Engineering Specialist** **Location:** Petaluma, CA (Onsite) **Employment Type:** Contract or Contract-to-Hire **Pay Rate:** $80-$90/hr **About the ... for multiple new product launches. We are seeking a ** Regulatory Engineering Specialist** who can bridge the gap between...+ Partner with engineering and quality teams to ensure FDA compliance on validations, CAPAs, and process changes. +… more
- Merck (San Diego, CA)
- …quality and compliance across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, ... in biological sciences, chemistry, or related discipline with 10+ years of relevant drug development, clinical, or regulatory experience. + MD or Ph.D./Pharm D… more