- J&J Family of Companies (Titusville, NJ)
- …the CDTL, DAS lead and with functional partners from global medical affairs, health care compliance , legal regulatory , and other relevant groups. + The VP NP is ... globally. Through this approach, we have become the industry leader in productivity, FDA approvals and breakthrough designations, with 13 new products since 2011 and… more
- Sumitomo Pharma (Trenton, NJ)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties… more
- Merck (Rahway, NJ)
- …Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + **CMC RA** : Experience supporting/writing … more
- Sokol Materials & Services (Skillman, NJ)
- …including plans, test protocols, summary reports, and traceability matrices, ensuring regulatory compliance and accuracy. * Investigate and resolve deviations ... principles and methodologies, including risk-based validation approaches. + Knowledge of regulatory requirements, including FDA , EMA, and ICH guidelines.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …comparator drugs and other co-meds for clinical studies . Mature knowledge of the FDA , cGMP, GCP standards and regulatory guidance documents such as CFR, Annex ... Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to develop… more
- Kelly Services (Somerset, NJ)
- …for the position. + Adhere to company standards for data integrity and regulatory compliance . **Education and Experience:** + Bachelor's degree in engineering, ... experience with QMS platforms (eg, MasterControl), LIMS, and ERP systems. + Familiarity with FDA 21 CFR Part 11 compliance and data integrity principles. +… more
- Lilly (Branchburg, NJ)
- …provide real-time insights to enhance process efficiency, product quality, and regulatory compliance . + Identify, recommend, and implement automated solutions ... and supports laboratory and/or manufacturing systems to meet business and regulatory needs. This position requires business area knowledge and computer expertise… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Review educational, promotional, and advertising materials to ensure clinical accuracy and compliance with regulatory standards. + Work collaboratively with R&D, ... advance scientific exchange and product innovation. + Offer clinical expertise for regulatory submissions and communicate with FDA and international authorities… more
- Sokol Materials & Services (Skillman, NJ)
- …facility qualification. + Strong understanding of validation principles, methodologies, and regulatory requirements, including FDA , EMA, and ICH guidelines. ... protocols, summary reports, and traceability matrices, ensuring technical accuracy and compliance with regulatory requirements. * Investigate and resolve… more
- Actalent (Basking Ridge, NJ)
- …with internal procedures. The role involves coordinating labeling projects to ensure regulatory compliance and providing guidance to team members on labeling ... to internal procedures. + Coordinate labeling projects to ensure regulatory compliance . + Provide guidance on labeling...Ability to take and follow directions. + Familiarity with FDA Labeling guidelines (21 CFR). + Excellent communication and… more