- J&J Family of Companies (Raritan, NJ)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director , Global Regulatory Affairs Diagnostics. This position is ... We invite candidates from any location to apply. The Associate Director , Global Regulatory Affairs Diagnostics will provide an opportunity to… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- The Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the company's ... quality issues. + **Compliance & Documentation** + Ensure supplier compliance with global regulatory requirements (eg, FDA, EMA, ICH). + Prepare documentation… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Job Summary** The Associate Director , Quality Operations will lead initiatives that drive operational excellence, enhance risk management practices, and ... **Compliance & Governance** + Ensure quality operations comply with global regulatory requirements (eg, FDA, EMA, PMDA)...within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs , IT, and other functions to… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …for assigned compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned ... activities related to all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.… more
- Sumitomo Pharma (Trenton, NJ)
- … Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily function ... as a regional regulatory leader (RRL) and/or Global ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead ( Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director Commercial Regulatory Affairs ** **Description** : The role ... of Associate Director of US Commercial Regulatory ...parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All… more
- GRAIL (Trenton, NJ)
- …with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- Bristol Myers Squibb (Madison, NJ)
- …. **Position Summary** Bristol-Myers Squibb is seeking an Associate Director , Principal Product Quality Leader (PQL), in Global Product Quality ... Stability, Analytical Development, Process Development, Manufacturing Sciences and Technologies, Regulatory Affairs , and other Cell Therapy Development… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …study report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study ... products for the maintenance of everyday health. As an Associate Director , Biostatistician, you will be a...key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical… more