- Rincon Consultants (San Luis Obispo, CA)
- …This includes close collaboration with peers, junior staff, clients, and regulatory agencies on complex, multi-disciplinary efforts. This position is ideally based ... and QA/QC of biological resource reports, CEQA/NEPA analyses, and regulatory permit applications with a focus on aquatic species...business development experience listed above + BS, MS, or PhD in Fisheries Biology, Aquatic Ecology, or a related… more
- Kelly Services (Pleasanton, CA)
- …Practice (GLP), Good Clinical Laboratory Practice (GCLP), and other applicable regulatory standards for our bioanalytical GLP lab. This role reports directly ... the CEO. **Schedule:** M-F, onsite **Responsibilities:** + Host client and regulatory inspections, including preparing and submitting responses to findings. + Audit… more
- 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
- 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 ... to government agencies. Prepare responses to technical issues from regulatory agencies on submitted studies. + Plan, direct, and...for identifying patentable inventions. Qualifications: + Typically, a MS, PhD or equivalent, with 9 - 12 years of… more
- Bristol Myers Squibb (San Diego, CA)
- …trials and will supervise and have accountability for the clinical components of regulatory filings + Will contribute to overall strategy for specific disease / ... and Communication + Will work closely with colleagues in BMS Research, Development, Regulatory , Medical, Commercial and other key functional areas on a global basis;… more
- Bristol Myers Squibb (San Diego, CA)
- …will work cross-functionally with several departments (Clinical Operations, CMC, Regulatory Affairs, Supply Chain, Drug Safety/PV, Compliance and Legal). ... area oversight to ensure quality of work and appropriate compliance with regulatory requirements + Conduct budget negotiations for Medical Affairs IITs, including… more
- AbbVie (South San Francisco, CA)
- …key Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers. Supports strategic planning for drug ... cost, quality/performance). + Provides scientific and strategic consultation to R&D, Regulatory , and all levels of management on critical decisions and development… 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
- AbbVie (Irvine, CA)
- …strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues. ... scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents. Lead development,… more