- Merck (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… 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. The… more
- J&J Family of Companies (Titusville, NJ)
- …affairs, and business development. * Familiarity with HCC laws, FCPA, FDA regulatory promotional practices, and financial/auditing practices. * Experience ... Required: * Bachelor's degree. * Minimum of 10 years of compliance experience ( Regulatory , Quality , Compliance, Legal). * Proven experience in people management… more
- 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
- Sanofi Group (Morristown, NJ)
- …possible. Ready to get started? **Main Responsibilities:** + Develop CMC regulatory strategies and assess associated risks for development projects and/or registered ... products (new products or marketed products) in collaboration with all Global Regulatory Affairs entities. + Participate in Change Control assessment. + Guarantee… more
- Actalent (Basking Ridge, NJ)
- …Perform other duties as assigned based on business requirements. Essential Skills + Quality assurance expertise. + Knowledge of FDA regulations. + Understanding ... + Ability to partner with members across departments like Regulatory and Quality to ensure compliance. +...of experience in pharmaceutical manufacturing. + 1-2 years of quality experience with pharmaceutical FDA submissions. Work… more
- Atlantic Health System (Union, NJ)
- …compliance. + Provides remediation as indicated. + Participates in in-services as required. REGULATORY COMPLICANCE (CAP, CLIA, JCAHO, FDA ) + Updates and monitors ... reports workload statistics to the Site Manager. + Reports Quality Control, Proficiency Testing and Quality Improvement...Ensures that technical manuals are in compliance with all regulatory agencies. + Performs duties of testing personnel as… more
- System One (Park Ridge, NJ)
- …+ Cross-Functional Collaboration + Partner with product development, packaging, operations, quality , and regulatory affairs to integrate microbiological and ... advantage + Expert Microbiology and Sterilization understanding + Demonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC + Strong… more
- Unilever (Englewood Cliffs, NJ)
- …- Representing and guiding Unilever as the face of Microbiology to external regulatory bodies ( FDA , CFIA, etc.) + Micro validation support (formulation advice ... knowledge of basic microbiological lab activities; direct expert guidance to Quality Assurance and factory personnel; and microbiological commissioning of new… more
- ARUNDEL MACHINE (Emerson, NJ)
- …or reworks as needed + Ensure the company's products comply with all FDA regulations, prepare submissions and maintain regulatory databases + Adhere strictly ... assessments + Document inspection results by inputting data into quality database, completing forms and logs, summarizing inspection findings...13485, EU MDR and company procedures to ensure the quality and integrity of the products and safety of… more