- J&J Family of Companies (Titusville, NJ)
- …monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical affairs ... adverse events (pre and post-marketing) for relationship to treatment** **Assists Regulatory Affairs in determining requirements for any corrective actions… more
- Merck (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Management Process, Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance {+ 5 more}… more
- Sanofi Group (Morristown, NJ)
- …diagnostic products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department ... **Job Title:** GRA Device Lead ( Director ) **Location** : Morristown, NJ, Cambridge, MA, Framingham,...within Global Research and Development. Sanofi's global regulatory affairs (GRA) function… more
- Merck (Millsboro, DE)
- …approve SOPs, Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs , EHS, Engineering, BTS, ATS and HR. + ... formulation and fill/finish activities. + Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT support for audits, inspections,… more
- J&J Family of Companies (Titusville, NJ)
- …via matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs , finance, legal, quality assurance, quality ... for the preparation and approval of essential documents for global regulatory filings. The CL will manage...emerging from the Team and its affiliates + Assists Regulatory Affairs in the development of drug/device… more
- Lilly (San Diego, CA)
- …test therapeutic hypotheses + Collaborate with clinical pharmacology, biostatistics, regulatory affairs , operations, and other stakeholders to optimize ... requirements for early clinical development (IND strategy, FDA interactions, global regulatory agencies) + Familiarity with target identification/prioritization… more
- J&J Family of Companies (Titusville, NJ)
- …monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical affairs ... events (pre and post-marketing) for relationship to treatment + Assists Regulatory Affairs in determining requirements for any corrective actions or health… more
- J&J Family of Companies (Titusville, NJ)
- …monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical affairs ... **POSITION SUMMARY:** The incumbent will serve as a Senior Director , Clinical Leader in Neurodegeneration, Neuroscience, with a focus...responding to medical and compound-related issues + Working with Regulatory Affairs and global clinical… more
- Takeda Pharmaceuticals (Boston, MA)
- …preferred. + 12+ years of experience in pharmaceutical/biotech industry, with 8+ years in regulatory affairs or R&D operations. + Proven track record of leading ... and foster adoption of new initiatives. + Business Acumen: Strong understanding of regulatory affairs and enterprise strategy. + Analytical Thinking: Capable of… more
- Danaher Corporation (Putnam, CT)
- …and cross-functional collaboration. This position reports to the VP, Quality Assurance and Regulatory Affairs and is part of the Quality Team located in ... - innovating at the speed of life. As a global leader in high-tech filtration, separation, and purification, Pall...cross-functional teams including Manufacturing, Operations, R&D, Supply Chain, and Regulatory Affairs . + Develop and manage the… more