- Bayer (Whippany, NJ)
- …regulatory project goals from development through life cycle; + Represents Global Regulatory Affairs on assigned global Project Teams; + Develops submission ... make a real difference, there's only one choice.** **Director Global Regulatory Strategy (Molecular Imaging, Pharmaceuticals)** The position is responsible for the… more
- J&J Family of Companies (Raritan, NJ)
- …master's degree, or PhD in life science, analytical science, data science, regulatory compliance or regulatory affairs , computer science, mathematics, ... with any statistical analysis tools + Awareness of quality management systems or regulatory requirements **FOR US ONLY:** Applicable pay range: $23 per hour to… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …support marketed products + Coordinates seamlessly with Clinical Operations and with Regulatory Affairs + Supervises the activities and the performance ... other senior managers within R&D and across the enterprise in defining regulatory strategy, developing programs to support commercial strategy, building the pipeline… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... study protocols are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans. The Clinical… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Merck (Rahway, NJ)
- …marketing teams within the organization along with sales, product development, regulatory affairs , customer service, and other cross-functional teams to ... of people management experience required + Strong understanding of regulatory requirements and challenges in marketing pharmaceuticals **Required Skills/Abilities:**… more
- Merck (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director May… more
- Merck (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Director May Be… more
- Merck (Rahway, NJ)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Clinical Director May Be… more
- Novo Nordisk (Plainsboro, NJ)
- … Regulatory Operations and works cross-functionally with internal departments on Regulatory Affairs related issues. Essential Functions + With direction from ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more