- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, ... Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled… more
- Bayer (Indianola, PA)
- …a deep understanding of user-centric development principles, industry best practices, and regulatory expectations (including those of US FDA , EMA/NBs, UK MHRA, ... + Proven experience in HF/UE submissions as well as in successful interactions with regulatory bodies, especially with the US FDA ; + Strong background in… more
- Capgemini (New York, NY)
- …(Big 4 or life sciences consultancies) in PV projects. + Involvement in regulatory inspections ( FDA /EMA GVP), and audit readiness. + Experience with REMS ... Role** As a Senior Consultant, you will act as a pharmacovigilance and drug safety expert for pharmaceutical and biotech clients, supporting safety across the… more
- Bristol Myers Squibb (Indianapolis, IN)
- …to support regulatory filing. . Author CMC sections for IND/NDA for FDA submissions, and support regulatory filing in other jurisdictions, eg EMA, Health ... motivated Sr. Scientist to lead the development and optimization of radiopharmaceutical drug products and radioisotopes. This position plays a pivotal role in… more
- Katmai (Brilliant, OH)
- …implementation, monitoring and maintenance of the Quality System in accordance with FDA Medical Device and Drug regulations. **ESSENTIAL DUTIES & ... Control. + Prepare documentation and systems for compliance with the FDA requirements. + Conduct and participate directly in quality inspections, internal… more
- Chiesi (Boston, MA)
- …portfolio-wide objectives. + Regulatory and Compliance: + Ensure RWE studies meet regulatory standards (eg, FDA , EMA guidelines) for use in submissions and ... innovation, empowering you to drive transformative changes that accelerate drug development and market entry on a global scale,...prefer for you to have + Experience working with regulatory agencies (eg, FDA , EMA) on RWE… more
- Sutter Health (Palo Alto, CA)
- …pharmacy, the Drug Enforcement Administration (DEA), and the Food and Drug Administration ( FDA ) by monitoring nursing unit inspections; maintaining records ... of Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). **Job Shift:**… more
- Cedars-Sinai (Los Angeles, CA)
- …Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary ... Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review Board. + Maintains research… more
- Taiho Oncology (Princeton, NJ)
- …biotech or related environment. + Minimum 7 years' experience in pharmacovigilance, drug safety, or regulatory labeling within the pharmaceutical or ... and others) are current, accurate, and compliant with global regulatory requirements for ICSR assessments. The position also supports...LSMV, Argus). + In-depth knowledge of relevant Food and Drug Administration ( FDA ), European Union (EU) and… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …visualization tools (eg, Power BI, Tableau). + Thorough knowledge of Food and Drug Administration ( FDA ), European Medicines Agency (EMA), and other applicable ... clinical operations expertise, cross-functional leadership, and deep understanding of regulatory , safety, and Medical Affairs frameworks. **Key Responsibilities** **OOS… more