- Bristol Myers Squibb (Summit, NJ)
- …Product Quality organization . The Sr. Director a uthor s designated sections of regulatory filing s , review s all sections for clarity, technical persuasiveness , ... and testing of cell banks, gene delivery materials , drug product intermediates, drug product, and finished...that comply with internal and external quality standards and regulatory requirements. + Provide global product quality oversight of… more
- Wells Fargo (Charlotte, NC)
- …Aligned Compliance Officer (BACO). The BACO for this area will serve as the regulatory subject matter expert in a diverse range of regulatory requirements. The ... the CFTC Swap Dealer within the Markets Division. This role will provide regulatory compliance advice to the business and support day-to-day compliance inquiries and… more
- University of Rochester (Rochester, NY)
- …of regulatory documentation for investigational products, including Investigational New Drug (INDs) and New Drug Applications (NDAs). + Implements and ... for clinical research conducted at CHeT. Ensures clinical data quality, regulatory compliance, and integrity of research documentation while collaborating with… more
- Houston Methodist (Houston, TX)
- …with accepted ethical and professional practices and all legal and regulatory requirements. The Director Pharmacy Services position shall establish and maintain ... the medical and nursing staff in monitoring and governing all aspects of drug use. This position also utilizes clinical and professional practice knowledge to… more
- Otsuka America Pharmaceutical Inc. (Salem, OR)
- …and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines, including ... drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards. **Competencies** **Accountability for Results… more
- Lilly (Indianapolis, IN)
- …benefit-risk management procedures, tools, and templates that will meet external regulatory requirements and Lilly standards across the product life cycle. This ... a strong working knowledge and understanding of regulations, guidelines, and regulatory precedence. The Senior Director will ensure that the Benefit-Risk Management… more
- Genentech (South San Francisco, CA)
- …and immunology required + In-depth understanding and recognized scientific leader in drug and biomarker development processes and regulatory requirements from ... and strategies to support clinical trials, and derive new research directions and drug discovery insights from patient samples and data. This role requires an… more
- Lilly (Indianapolis, IN)
- …( Drug Product Delivery, Project Management, Quality, Manufacturing, and Regulatory ) to implement and deliver material and information for clinical trials ... active pharmaceutical ingredients (API) from pre-clinical phases through commercialization of drug substances and drug products. Our chemists, engineers, and… more
- AbbVie (North Chicago, IL)
- …of innovative small molecule medicines, including New Chemical Entities (NCEs), Antibody Drug Conjugate (ADC) drug linkers, peptides and oligonucleotides and ... through commercial manufacturing. He/she will partner cross-functionally to drive robust drug substance and drug product manufacturing process development by… more
- Fujifilm (Salem, OR)
- …established policies and procedures. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO ... site visits, as necessary. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties inherent… more