- Dr. Reddy's Laboratories (Princeton, NJ)
- …standpoint, identify and respond to signal analysis, and submit to regulatory agency ( FDA /Health Canada) within timelines to achieve 100% compliance with US ... norm + Anchor drug safety regulatory inspection in US ( FDA regulatory agencies),participate in audits and provide support in...to be documented and set up. Establish the pharmacovigilance Quality Management System and achieve compliance with… more
- Integra LifeSciences (Princeton, NJ)
- …projects, and work cross-functionally. + Detail-oriented with a commitment to maintaining high- quality standards and regulatory compliance . + Experience with ... learn about bacterial endotoxin testing programs, an understanding of medical device quality systems, and a commitment to ensuring product safety and compliance… more
- Unilever (Englewood Cliffs, NJ)
- …for North America, with a focus on R&D - Interfacing with and ensuring compliance of external micro labs to our testing requirements and standards - Representing and ... as the face of Microbiology to external regulatory bodies ( FDA , CFIA, etc.) + Micro validation support (formulation advice...Microbiology for North America + Interfacing with & ensuring compliance of external micro labs to our testing requirements… more
- Sanofi Group (Morristown, NJ)
- …efficient prioritization of multiple requests, delegation as needed, and delivering high- quality service to business partners. Confidence working with senior leaders ... counsel concerning a broad range of legal issues, including, interpretation of FDA and other regulations, including the False Claims Act, Anti-Kickback Statute and… more
- Actalent (Fair Lawn, NJ)
- …preferably in a regulated industry . Strong understanding of GMP, GDP, and FDA quality system regulations . Demonstrated ability to lead cross-functional ... Quality Process Engineer Overview: The Quality ...transition manufacturing activities from external suppliers. The engineer ensures compliance with GMP, GDP, and regulatory standards while driving… more
- Fujifilm (Trenton, NJ)
- …vendor agreements, non-disclosure agreements, development, manufacturing and service agreements, quality agreements and clinical trial and research agreements, among ... legal risks and regulatory risks, including with respect to FDA regulations and other regulations specific to Life Sciences/Pharma...Experience in legal matters involving tariffs and other trade compliance issues would be a plus. + Strong contract… more
- Bayer (NJ)
- …and accurate implementation of new and revised labeling in accordance with FDA requirements and provides regulatory expertise and guidance for labeling operations ... and strategy to deliver high quality submission labeling. The position also facilitates strategic development...evaluates requests for new or revised labeling initiated by FDA or Bayer HealthCare Pharmaceuticals and manages action required… more
- System One (Florham Park, NJ)
- …documents. + Conduct review of published submissions to ensure consistency and compliance with regulatory requirements. + Perform quality control checks on ... in the preparation and submission of electronic regulatory documents through the FDA and Health Canada Electronic Submission Gateways (ESG), as well as, prepare… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …and provide technical expertise for evaluation and feedback of methods. + Ensure compliance with regulatory requirements (eg, FDA , EMA) and industry standards ... develop, enable and e xecute analytical and CMC strategies that ensure safety, quality and efficacy of life - saving medicines administered to patients in clinical… more
- Actalent (Basking Ridge, NJ)
- …Perform other duties as assigned based on business requirements. Essential Skills + Quality assurance expertise. + Knowledge of FDA regulations. + Understanding ... of SOPs. + Ability to partner with members across departments like Regulatory and Quality to ensure compliance . + Proficient knowledge of GMP and Quality … more