- Merck (Rahway, NJ)
- …data. + Produce tables and graphics for inclusion in study reports and regulatory submissions . + Produce SAS transport files and associated documentation for ... regulatory submissions . + Assure deliverable quality and compliance with departmental SOPs and good programming practices. + Collaborate effectively with project… more
- Actalent (East Windsor, NJ)
- …and other regulatory guidelines. + Assist in preparing documentation for regulatory submissions and audits (internal and external). + Maintain accurate ... and Analytical Development. Your role will ensure compliance with regulatory guidelines, support collaborative efforts, and contribute to continuous improvement… more
- Astrix Technology (New Brunswick, NJ)
- …SDS-PAGE, ELISA, capillary electrophoresis, and cell-based assays.** + Familiarity with preparing regulatory submissions and data packages for interactions with ... of analytical methods, ensuring data integrity and compliance with regulatory requirements. **Essential Duties & Responsibilities** + Perform analytical testing… more
- AbbVie (Florham Park, NJ)
- …of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. + Has overall responsibility for ... activities with internal stakeholders (ie, commercial, clinical operations, discovery, statistics, regulatory , etc ) as they relate to on-going medical affairs… more
- Actalent (East Windsor, NJ)
- …and other regulatory guidelines. + Assist in preparing documentation for regulatory submissions and audits. + Maintain accurate version control and document ... will ensure all documentation is consistent, clear, and compliant with regulatory guidelines, while maintaining accurate version control and document tracking.… more
- Sanofi Group (Morristown, NJ)
- …supply management experience + Knowledge of pharmaceutical manufacturing quality systems and regulatory submissions process. + Knowledge of systems and tools ... lead, M&S & GBU Finance, Industrial Product Lead & Regulatory Affairs Our team is responsible for the End-to-End...set of products (safety stock, manage LCM timelines with Regulatory , target split between sourcing nodes, distribution network). +… more
- Colgate-Palmolive (Piscataway, NJ)
- …of new chemicals/ingredients. + 0-3 years of experience preparing safety dossiers for regulatory submissions . + 0-3 years developing and implementing strategy to ... with internal entities such as the Product Development, Legal and Regulatory departments as well as external groups including subsidiaries, trade associations… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …development and ability to provide programming support and leadership for BLA and other regulatory submissions . + Experience in working on a submission to ... quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports. If applicable, programming representative… more
- SMBC (Jersey City, NJ)
- …comprehensive reports and documentation to support stress test results and regulatory submissions + Continuous Improvement: Contribute to ongoing enhancements ... management of stress testing processes, ensuring robust risk management and regulatory compliance. **Role Objectives** + Scenario Development: Apply and leverage… more
- Stryker (Mahwah, NJ)
- …literature, extract data, interpret trends, and communicate scientific findings to support regulatory body submissions for diverse geographies. You will apply ... + Prepares clinical documentation to validate device safety and performance for regulatory body submissions and perform periodic updates to maintain compliance… more