- Takeda Pharmaceuticals (Lexington, MA)
- …proficient understanding of scientific principles and profound grasp of global regulatory CMC requirements relevant to global drug development and post-market ... This role is within in the R&D GRA Chemistry Manufacturing & Controls ( CMC ) and Devices organization, and will contribute to the team's delivery of critical… more
- Takeda Pharmaceuticals (Boston, MA)
- …part of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + ... therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you...oversee the development and execution of regulatory CMC development and registration strategies. You will… more
- Takeda Pharmaceuticals (Lexington, MA)
- …relevant industry experience + Minimum of 10 years of experience working in CMC analytical development area for active pharmaceutical ingredients and drug ... their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all… more
- Takeda Pharmaceuticals (Lexington, MA)
- …leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory, CMC or other drug development related function. Clinical ... is true to the best of my knowledge. **Job Description** **Associate Director , Clinical Research, Value & Evidence Generation, US Medical** **Lexington, MA**… more
- AbbVie (Cambridge, MA)
- …one aspect of Drug Development (eg, pre-clinical research, clinical development , Regulatory Affairs, Chemistry Manufacturing and Controls ( CMC )). + ... part of the Corporate Strategy Office and actively supports global Business Development (BD) goals by sourcing and assessing external partnering opportunities that… more
- Fresenius Medical Center (Waltham, MA)
- …NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership in medical/clinical development , commercial, and other functional ... the integration of regulatory considerations into all stages of product development , including preclinical, clinical/medical, CMC , and post-market phases. +… more
- AbbVie (Worcester, MA)
- …and improvement of Quality metrics used for management review in partnership with senior leadership to develop a clear picture of overall compliance state and ... local / global project implementation. + Leads product quality team to support development of the legal supply agreements, contractors or letters of intent to ensure… more