- Actalent (Cambridge, MA)
- …responses to agency questions, and maintenance activities. + Coordinate and drive regulatory CMC submissions, including necessary cross functional teams and ... Description + Actively represent Regulatory on interdisciplinary teams (eg CMC ...self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for… more
- Takeda Pharmaceuticals (Boston, MA)
- …development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and ... and transfer; + Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about… more
- Takeda Pharmaceuticals (Boston, MA)
- …with significant experience within related functions (eg Marketing, Clinical Operations, Regulatory , Manufacturing, CMC , Clinical Science) + Minimum of 3 ... Team (GPT) strategy into an efficiently executable plan working closely with a senior GPM; predicting and planning solutions to achieve program goals and objectives;… more
- Amgen (Cambridge, MA)
- …as financial systems and controls. + Understanding of cGMP, Operations and Regulatory / CMC policies and requirements + Knowledge of the contract manufacturing ... the lives of patients while transforming your career. Contract Development and Manufacturing Manager **What you will do** Let's do this. Let's change the world. In… more
- Takeda Pharmaceuticals (Boston, MA)
- …versatile and strong enterprise leaders + be committed to simultaneously driving regulatory approval as well as product launch and global patient access + ... the GPL on the sub-team objectives. + Accountable with the Global Program Manager for operating budgets within the global program; leads budget setting in… more
- Takeda Pharmaceuticals (Boston, MA)
- …experienced, versatile and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global patient access + Ability ... on the sub-team objectives. + Accountable with the responsible Global Program Manager for activities operating budgets within the global program; leads budget… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …significant experience within related functions (eg Clinical Science, Clinical Operations, Research, Regulatory , CMC , Marketing) * Minimum of 5 years program ... analyses to communicate program development progress, opportunities, and risks to Senior & Executive Management. * Responsible for coordinating preparation efforts… more