- Katalyst HealthCares and Life Sciences (Cambridge, MA)
- …requirements and standards are properly and timely implemented. Provide support to Regulatory CMC managers in developing strategy for development projects, ... back-up projects. Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update to the teams on follow-up actions,… more
- AstraZeneca (Boston, MA)
- …medicine, regulatory , biostatistics, safety, cell therapy delivery team (including CMC ), and commercial colleagues as part of a cross functional team. Closely ... governance interactions and with external partners (as aligned with senior manager ), including Investigators, key external authorities and patient advocacy groups… more
- Deloitte (Boston, MA)
- …(ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years ... equitable future of health. Work You'll Do As a Manager you will lead and deliver engagements, or components...+ 4+ years Life Sciences Chemistry, Manufacturing, and Controls ( CMC ) experience to include: + Introducing new technologies like… more
- Cardinal Health (Boston, MA)
- …to Cardinal Health_** The _Scientist I, Chemistry, Manufacturing, and Control ( CMC )_ ensures efficient and quality production of product submission dossiers for ... Cardinal Health's Regulatory Science clients. Working remotely under the supervision of the CMC Supervisor, the Scientist I builds and formats Common Technical… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Deloitte (Boston, MA)
- …health Recruiting for this role ends on 7/31/2025 Work You'll Do As a Manager you will lead and deliver engagements, or components of large, complex engagements. ... experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and… more
- BeOne Medicines (Cambridge, MA)
- …and provide a high service level to internal stakeholders (eg Clinical Operations, Regulatory , Quality, CMC ). + Work with Clinical Operations to understand ... BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Sr. Manager , Clinical Supply Chain in Cambridge, MA: **Job Duties:** + Represent the Clinical Supply Chain on Clinical… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). + Minimum of 5 years' experience as… more
