- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC , is responsible for the regulatory CMC ... siRANdrug projects consistent with the company goals. Participate on G- RACMC teams and support or lead on Component teams...support or lead on Component teams and/or serve as G- RACMC lead or regional submission lead. Provide regulatory guidance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …working relationships with internal and external stakeholders. Coordinate with lab units, SC, RACMC , QA to drive collaboration and solves issues in Tech Mgmt. (mAb, ... Drug Substance, Drug Product, or New Modality) team.- Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses to regulatory questions, briefing books. Qualifications: Successful… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC , is responsible for the regulatory CMC ... siRANdrug projects consistent with the company goals. Participate on G- RACMC teams and support or lead on Component teams...support or lead on Component teams and/or serve as G- RACMC lead or regional submission lead. Provide regulatory guidance… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible ... project teams, and supports change implementation. Coordinates with regional/global RACMC , Quality Assurance, Pharmaceutical Technology, and other functional areas… more
