- 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)
- …diseases, researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical, 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs, is responsible for the development ... pertain primarily to marketed products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs, in collaboration with Head, Regulatory… more
- Merck (Rahway, NJ)
- …analysis and provides recommendation to governance for endorsement. Represents CMC and effectively communicates across the governance bodies, stakeholders and ... stakeholders. Influences and challenges the xDT strategy to ensure a robust CMC strategy is achieved. Identifies options to balance Speed/Cost/Robustness & achieve… more
- MTA (New York, NY)
- …: $128,000-$140,000 HAY POINTS : 805 DEPT/DIV: HR Center of Excellence SUPERVISOR : Senior Director , HR Center of Excellence LOCATION : 333 West 34th Street ... to control costs and optimize resources. + Other assignments as directed by the Senior Director . KNOWLEDGE, SKILLS, AND ABILITIES + Excellent ability to manage a… more