- LA Care Health Plan (Los Angeles, CA)
- …with business units in audit universe preparation and validation. Assists in document preparation for regulatory and internal audits. Regulatory ... the guidelines and protocols to ensure readiness for all regulatory audits. This position will develop, with the assistance...the deficiencies. This position will be responsible for the regulatory obligations for each line of business and their… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …working in the pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Envista Holdings Corporation (Brea, CA)
- **Job Description:** The ** Regulatory Affairs Associate** (RAA) supports the RA team in creating, evaluating and completing regulatory tasks related to worldwide ... growth worldwide. This individual is responsible for driving global regulatory registrations/approvals based on company objectives, collaborating with cross-functional… more
- Gilead Sciences, Inc. (Foster City, CA)
- … strategies. + Under the guidance of more senior staff, oversees the preparation of CMC regulatory submissions for investigational and commercial products with ... Gilead and help create possible, together. **Job Description** This exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory Affairs… more
- AECOM (Sacramento, CA)
- …world. Join us. **Job Description** **AECOM** is seeking a talented **Senior Regulatory Specialist and Project Manager** to join our Northern California Natural ... services involving site selection and linear routing, feasibility studies, regulatory permitting, and environmental compliance. Technical responsibilities of this… more
- Medtronic (Irvine, CA)
- …on regulatory and internal policy requirements. + Support the preparation of US and International promotional labeling material, including the creation of ... promotional material to ensure that it meets all medical, legal, and regulatory (MLR) process requirements. + Facilitate review meetings online and offline… more
- Sharp HealthCare (La Mesa, CA)
- …on all nuclear medicine equipment. Procedures performed include preparation , administration, documentation and quality control of radiopharmaceuticals with ... of the Radioactive Materials License and all California State and Federal regulatory requirements. Assist staff with providing care to patients who have been… more
- Sharp HealthCare (San Diego, CA)
- …position requires the ability to combine clinical/quality considerations with regulatory /financial/utilization review demands to assure patients are receiving care ... level of care.The RN CM I will recommend and document patient classification (status and level of care) for...CM I has accountability for maintaining compliance contractual and regulatory compliance with medical groups as applicable and the… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** + This position supports Regulatory Affairs personnel in the coordination, preparation , and submission of all INDs/NDAs/MAAs and life ... knowledge of Adobe Acrobat PDF Bookmarks and Hyperlinks. + Experience with document management and Regulatory Information Management Systems (RIM). **Travel:**… more
- ThermoFisher Scientific (West Hills, CA)
- …and/or work instructions + Show initiative and ownership with assisting in document preparation /presentation for regulatory agency visits and ... Corporate/internal audits + Provide real-time support to Product Packaging and Labeling to prevent backorders, non-conforming materials release and adherence to the production schedule + Maintain quality, compliance, and safety following laws, policies, and… more
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