- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. As a Senior Director of Quality Assurance CMC , you will be responsible for providing ... Engineering or related fields" + 15+ years of progressive GMP/ CMC Quality Assurance experience with 7+ years...ability to inspire and motivate direct reports at the director level and below. + Ability to work independently… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take main responsibility for … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …managers, development program managers, medical monitors, as well as staff from quality , clinical compliance, regulatory, formulations, and IOPS ( CMC , external ... The ** Sr Manager, Clinical Drug Supply & Logistics** is...are performed on time, within budget and with good quality , in compliance with Regulatory Authorities' regulations / guidelines… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Development, may be called upon to ... plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also...claims. + Acts as liaison between Regulatory Affairs & CMC and other functional areas, including external contractors (eg,… more
- Organon & Co. (Jersey City, NJ)
- …the Executive Director in Organon's Regulatory Chemistry, Manufacturing and Controls ( CMC ) New Products, the Senior Scientist is responsible for implementing ... in accordance with global regulations, guidances and defined regulatory strategies. The Senior Scientist is responsible for the preparation and review of information… more