- Sanofi Group (Morristown, NJ)
- …endpoint strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, ... new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research and Development… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Other Requirements** + In-depth understanding of US Food & Drug Administration ( FDA ) and European Medicines Agency (EMA) regulatory requirements and ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more
- Edgewell Personal Care (Allendale, NJ)
- …Chain, Quality Assurance, Regulatory Affairs, or Operations Analytics + Exposure to regulatory standards such as FDA , EU MDR, ISO 13485 or GMP preferred ... our shared achievements. **POSITION SUMMARY** The **Global Supply Chain Analyst - Regulatory & Quality (Data & Analytics Focus)** is responsible for delivering… more
- System One (Fairfield, NJ)
- …within a food, flavor, or dairy manufacturing environment + Familiarity with FDA , GMP, HACCP, and regulatory compliance requirements + Proficiency in ... highest standards of food safety, product integrity, and compliance with regulatory guidelines. This position supports production by validating line setup, auditing… more
- Merck (Rahway, NJ)
- …ideas, but also have pragmatic approach to development options, technology selection and regulatory posture + Demonstrated working knowledge of FDA , ICH, and ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. These sterile products… more
- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... level of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties… more
- Fujifilm (Trenton, NJ)
- …II + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... and/or HCUS's future business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job duties inherent in the… more
- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... 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
- Fujifilm (Trenton, NJ)
- …- I. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... and/or HCUS's future business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job duties inherent in the… more
- Fujifilm (Trenton, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... 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