- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines, ... collection, storage conditions, and analytical testing, to support product development and regulatory submissions. + Author and review INDs, NDAs, and other … more
- AbbVie (South San Francisco, CA)
- …of a team. Lead/develop statistical strategy for project development and regulatory submission. + Provide statistical leadership for design, analysis and reporting ... drive alignment with functional management. Partner with other functions (Clinical, Regulatory , Patient Safety, and GMA, etc.) to create development strategies for… more
- Stantec (Irvine, CA)
- …Biologist, you will oversee and provide expertise in field biology, regulatory strategy, CEQA/NEPA analysis, and permitting strategy. Specific background and ... of excellent botanical, wetland, or wildlife technical expertise, expertise with regulatory permitting, and proven success in project and client management. This… more
- Valent BioSciences (San Ramon, CA)
- …for insuring that assigned studies are conducted in compliance with regulatory Good Laboratory Practice and FIFRA guidelines. Monitor and be accountable ... for submission to government agencies. Prepare responses to technical issues from regulatory agencies on submitted studies. + Plan, direct, and execute laboratory… more
- CSL Plasma (Fairfield, CA)
- …This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and ... of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible ... and follow-up of internal and external audits to ensure compliance with regulatory requirements. + ** Regulatory Authority Engagement:** Act as the primary… more
- AECOM (San Diego, CA)
- …candidate will have:** + Strong working knowledge of environmental regulatory requirements for projects in California. + Strong interpersonal, organizational, ... Experience working with design teams to avoid, minimize and streamline environmental regulatory permitting. + Ability to apply acquired expertise and knowledge to… more
- Stantec (Santa Barbara, CA)
- …with other biologists/ecologists/water resource specialists, and land planning and regulatory experts. This position will include opportunities for both field ... Biologist, you will oversee and provide expertise in field biology, regulatory strategy, CEQA/NEPA analysis, and permitting strategy. Specific background and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …key role in shaping clinical strategy, collaborating cross-functionally with research, regulatory , safety, and commercial teams to advance innovative therapies that ... of clinical trial protocols for inflammation programs, ensuring scientific rigor and regulatory compliance. + Serve as the clinical lead on cross-functional study… more
- Amgen (Thousand Oaks, CA)
- …process technology transfer and other technical documents. **Process Validation & Regulatory Support** + Development of validation plans and supports execution of ... + Ensure site's process validation business process adheres to global regulatory agency standards, Amgen's quality requirements, other site policies and procedures,… more