- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …values and will be responsible for providing statistical expertise/input in the drug development including clinical development plan and regulatory submission ... regarding study design and complex analysis issues, FDA issues, and general drug development. + Reviews clinical, statistical, and regulatory literature for… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance. + Ensures adherence to regulatory requirements ... manner in line with the department and corporate goals and within regulatory and resource guidelines. **Job Responsibilities** + Provides ongoing medical monitoring… more
- Sumitomo Pharma (Sacramento, CA)
- …submissions. + Participate in all validation activities pertaining to commercial products ( regulatory starting materials, drug substances, and drug ... with multiple therapeutic modalities (eg API, solid dosage, biologics, gene therapies, drug /device combination products) is required. Must be familiar with EMA and… more
- PCI Pharma Services (San Diego, CA)
- …across our global network to pioneer and shape the future of PCI. The Drug Product Manufacturing Associate I - Formulations is responsible for the implementation of ... manufacturing procedures to support processes and ensure compliance with regulatory requirements. The Associate I will work with the... requirements. The Associate I will work with the Drug Product team to ensure the successful completion of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …teams,linemanagementand CROs toassurehigh quality andtimelydelivery of written PK reports and regulatory documents (IND, IMPD, IB, BLA) for regulatory ... + Ph.D. with 3+ years of post-graduate industry experiencein pharmacokinetics, drug metabolism, pharmaceutics, or a related life science field, with a… more
- AbbVie (Irvine, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description 2026 Drug Product Development Intern Overview Envision spending your summer working ... intern will support the formulation development of protein biologics in the Drug Product Development group. This position requires laboratory work. The candidate… more
- Abbott (Sylmar, CA)
- …other regulatory requirements. + Complies with US Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating ... Collaborating with other organizations within the company as needed: engineering, regulatory , human factors,quality, marketing,etc + Provides input to the risk… more
- Abbott (Sylmar, CA)
- …other regulatory requirements. + Complies with US Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating ... Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures. As a global leader in Cardiac Rhythm… more
- Actalent (San Clemente, CA)
- …-eluting temporary stent program. This role will focus on in-house manufacturing, drug coating processes, equipment validation, and regulatory submissions in ... + Lead quality engineering activities for the development and manufacturing of drug -eluting stents. + Oversee drug coating processes, ensuring compliance with… more
- Abbott (Sylmar, CA)
- …of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. *Complies with US Food and Drug Administration ... from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. Medical device industry experience preferred. Professional… more