- Fujifilm (Trenton, NJ)
- …+ Advise, counsel and report to management on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations ... in the development and structuring of new business ventures. + Keep abreast of legislative and regulatory changes that may affect HLUS and its subsidiary companies.… more
- Sanofi Group (Morristown, NJ)
- …legal issues (focusing on antitrust matters, potential litigations and promotional matters, FDA / regulatory issues and fraud and abuse) as well as proposed ... furthers the company's strategic goals while effectively managing legal and regulatory risks and upholding the company's integrity and reputation. Additionally, the… more
- Atlantic Health System (Union, NJ)
- …+ Participates in in-services as required. REGULATORY COMPLICANCE (CAP, CLIA, JCAHO, FDA ) + Updates and monitors laboratory compliance with regulatory ... or healthcare setting, with a solid understanding of laboratory operations and regulatory compliance + In-depth knowledge of Clinical Laboratory principles,… more
- Kedplasma (Cinnaminson, NJ)
- …with cGMP, KEDPLASMA DCOP's and other Company standards and protocols to meet regulatory requirements of the FDA , EMEA, Customer Specifications, and other ... scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...of all DCOPs prior to implementation and confirming DCOP compliance with all applicable statutory and regulatory … more
- Merck (Rahway, NJ)
- … FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory ... 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR a… more
- Actalent (Basking Ridge, NJ)
- …processes related to labeling updates. + Coordinate labeling projects to ensure regulatory compliance . + Facilitate project completion through effective and ... Essential Skills + Quality assurance expertise. + Knowledge of FDA regulations. + Understanding of SOPs. + Ability to...+ Ability to partner with members across departments like Regulatory and Quality to ensure compliance . +… more
- Merck (Rahway, NJ)
- …Plant Maintenance, Preventative Maintenance Programs, Process Control Systems, Project Management, Regulatory Compliance , Regulatory Requirements {+ 3 more} ... NJ Campus. This role ensures HVAC systems comply with regulatory standards (eg, FDA , cGMP), maintain optimal...Develop, implement, and maintain HVAC operational strategies that ensure compliance with GxP (as applicable) and other regulatory… more
- Integra LifeSciences (Princeton, NJ)
- …processes are integrated into the overall product risk management process. ** Regulatory Compliance & Documentation:** + Ensure thorough documentation and ... and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + This position… more
- Integra LifeSciences (Princeton, NJ)
- …sterilization processes are integrated into the overall supplier quality process. ** Regulatory Compliance & Documentation:** + Ensure thorough documentation and ... and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + This position… more
- Actalent (Princeton, NJ)
- …to identify trends and areas for improvement. + Ensure compliance with FDA , EMA, and other applicable regulatory standards for cell therapy products. + ... have experience in GMP environments and a strong understanding of regulatory requirements for advanced therapy medicinal products (ATMPs). Responsibilities + Lead… more