- Fujifilm (Des Moines, IA)
- …established policies and procedures. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO ... to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties inherent… more
- Abbott (Plymouth, MN)
- …other regulatory requirements. + Complies with US Food and Drug Administration (FDA) regulations, ISO-13485 other regulatory requirements, Company policies, ... operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. + Performs other related duties and responsibilities, on occasion, as… more
- AbbVie (Irvine, CA)
- …senior executives + Experience of how different elements (discovery, development, regulatory , commercial etc.) fit together in the drug commercialization ... brands (Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs, etc., and substantial… more
- AbbVie (North Chicago, IL)
- …key Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers. Leads strategic planning for ... drug development activities and projects to achieve departmental strategies,...+ Provides expert scientific and strategic consultation to R&D, Regulatory , and all levels of management on critical decisions… more
- Boehringer Ingelheim (Athens, GA)
- …robust command of pharmaceutical sciences, including small molecule and biologic drug development, analytical chemistry, formulation science, and regulatory CMC ... is responsible for providing new product and marketed product regulatory strategy in the Global Regulatory Affairs...without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must… more
- Organon & Co. (Plymouth Meeting, PA)
- …labeling documents (CCDS) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU and most of ... labeling documents for company products, including core, US and supporting country regulatory affiliates for consistency of labeling documents around the world. +… more
- Bank of America (Charlotte, NC)
- …sanctions risk assessment methodology aligned with industry best practices, regulatory expectations, and the company's risk appetite. This includes conducting ... of America policy, applicable financial crimes laws and regulations, regulatory guidance and compliance, and industry best practices +...the dangers and resulting consequences of illegal and illicit drug use and alcohol abuse. Our Drug -Free… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …that all manufacturing, testing, packaging, storage, and distribution activities meet regulatory standards and deliver the highest product quality. The Sr. Director ... be made within the requirements of cGMPs and applicable regulatory /industry guidance documents. + Manage approval or rejection of...function including experience in manufacturing and control of bulk drug substances, and solid dosage form drug … more
- Sanofi Group (Morristown, NJ)
- …ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an… more
- Sanofi Group (Morristown, NJ)
- …ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... possible. Ready to get started? **Main Responsibilities:** + Develop global regulatory CMC strategies and risk assessments for development projects and/or marketed… more