- Charles River Laboratories (Ashland, OH)
- …methods from the method development are fit-for-purpose, and ready for FDA /EMA validation guidelines (where appropriate). + Ensure on-time and quality delivery ... more
- Integra LifeSciences (Anasco, PR)
- …and international regulatory submissions. 32.Participates in external audits such as: FDA , Notified Body (BSI) and Corporate, among others. 33.Will partner with ... more
- Abbott (Columbus, OH)
- …needs through understanding of nutrition product labeling requirements, including branding, FDA requirements and regulations. + Work with cross functional depts to ... more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …for consistent messaging. + Serves as the primary contact/liaison with the FDA Office of Prescription Drug Promotion (OPDP), responsible for establishing working ... more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …to ensure clarity and enforceability; + Maintain current awareness of evolving FDA laws and regulations, as well as interpretations, advisory comments, enforcement ... more
- Lundbeck (Columbus, OH)
- …and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. ... more
- Fujifilm (Columbus, OH)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements, and all ... more
- Cardinal Health (Columbus, OH)
- …manner while enforcing Cardinal Health compliance and regulations concerning OSHA, DEA, FDA , State and local authorities. + Enforces Cardinal Health compliance and ... more
- Abbott (Columbus, OH)
- …and current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA 's Computer Software Assurance initiatives are preferred. + Application of knowledge ... more
- Bayer (Columbus, OH)
- …Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and ... more
- Fujifilm (Columbus, OH)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... more
- Sumitomo Pharma (Columbus, OH)
- …goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and ... more
- BrightSpring Health Services (Groveport, OH)
- …for supporting Quality Assurance (QA) activities in compliance with FDA /DEA/State Regulations, cGMP, and company policies, procedures and specifications at ... more
- Amgen (New Albany, OH)
- …maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area. The work schedule for ... more
- Battelle Memorial Institute (West Jefferson, OH)
- …approves Provantis study setups. + Participates in all required training. + Follows FDA GLP and other appropriate regulatory (eg, OECD, ICH) requirements to ensure ... more
- Hologic (Newark, DE)
- …Familiarity with medical device regulations (21CFR820, ISO 13485, MDD) and FDA standards. + Knowledge of microbiology, molecular biology, biochemistry, chemistry, or ... more
- Bristol Myers Squibb (Princeton, NJ)
- …risk management and compliance with local and international PV regulations (eg, FDA , EMA, ICH). . Oversee end-to-end PV activities, including case processing, safety ... more
- Astellas Pharma (Northbrook, IL)
- …statistical modeling for observational research. + Knowledge of regulatory guidelines ( FDA , EMA, PMDA) on RWE, external control arms, and benefit-risk assessment. ... more
- Kedplasma (Phoenix, AZ)
- …Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... more
- Aerotek (Bethlehem, PA)
- …putting products away. Attention to detail is crucial as you will be handling FDA -regulated products. Quality is more important than quantity in this role, and you ... more