- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and ... statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in… more
- Abbott (Alameda, CA)
- …with all levels of the organization. + Ensure all automation processes comply with FDA , ISO 13485, and other relevant regulatory standards. + Maintain detailed ... streamline product return workflows, and ensure compliance with global regulatory standards. By aligning business needs with technical capabilities, this… more
- Turner Mining Group (Salinas, CA)
- …per LNA procedures. SAFE QUALITY FOOD (SQF): + Ensure a SQF workplace and in regulatory compliance with Federal FDA - Food Modernization Safety Act (CFR Code of ... and continued for existing employees. + Actively participate in audits for regulatory , safety, SQF and environmental compliance at the site. ATTRIBUTES: +… more
- J&J Family of Companies (Santa Clara, CA)
- …of each complaint. + Complete adverse event reporting determinations per geography regulatory requirements for approved devices ( FDA , EU MDD/MDR, PMDA, TGA ... for the treatment of calcified plaque. **Position Overview** In compliance with FDA , European MDD/MDR & other International Regulations, the Complaints Specialist I… more
- Abbott (San Diego, CA)
- …cybersecurity into the product lifecycle** , ensuring our devices meet regulatory requirements and protect patient safety. We're looking for a candidate ... will code, support threat modeling, risk assessments, vulnerability management, and regulatory compliance, and also ensure our products are secure and resilient.… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …and efficiency.Maintain a quality presence to ensure compliance with all regulatory requirements.Maintain current knowledge of regulatory and industry ... investigations performed for out-of-specification results or out-of-procedure events.Participate in regulatory and internal inspections/audits including providing written responses as… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to ... design and deliver impactful learning programs using adult learning principles. + Experience with learning technologies (eg, LMS, virtual learning platforms) and data-driven training strategies. + Excellent communication, collaboration, and stakeholder… more
- Gilead Sciences, Inc. (Foster City, CA)
- …translational science, biomarker strategy, and early clinical trial design. + Regulatory knowledge: Familiarity with FDA /EMA guidance for preclinical and ... early clinical phases. + CMC awareness: Understanding of drug substance/product development and manufacturing timelines. + Possess strong business acumen to align drug development and launch strategies with commercial goals, assess financial implications, and… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …develop department training programs, as needed + Hosts 3rd Party Audits from regulatory bodies including the FDA , notified bodies and business. **Knowledge, ... Skills, and Abilities** + Excellent writing skills, including independently writing SOPs, forms, and risk assessments. Must be a strong technical writer. + Excellent presentation skills, including independently preparing, organizing and presenting information… more
- Charles River Laboratories (Northridge, CA)
- …review of Quality Agreements, MSAs and SOWs for Commercial Team, regulatory agencies, and industry best practices. Essential Responsibilities + Provides technical ... the Donor Center operations best practices and adjustments needed to meet regulatory requirements and also to best support commercial revenue generation. + In… more