- Merck (Rahway, NJ)
- …In summary, our team enables the translation of preclinical candidates into non-oral drug products. We are seeking a highly motivated candidate for the position of ... Principal Scientist (R5) focused on developing parenteral drug products across a range of modalities (small molecule, peptides, proteins, antibody- drug … more
- Charles River Laboratories (Memphis, TN)
- …worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ... qualification deliverables, validation documentation, and validation activities comply with regulatory requirements for computer system validation. Support client and… more
- AbbVie (North Chicago, IL)
- …ensuring that the CMC submission strategy is aligned closely with the clinical/ regulatory development strategy and provides drug development experience and ... time pressure. Drive team resolution and author responses to questions from regulatory authorities. + Leverage extensive biologics drug development experience to… more
- Wells Fargo (New York, NY)
- …strategic advisory and operational compliance responsibilities, ensuring robust regulatory compliance across asset-backed lending, securitization and syndication. ... you will:** + Serve as a subject matter expert on regulatory requirements impacting Structured Products Group (SPG) including Regulation Asset-Backed Securities… more
- 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
- 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
- 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
- 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