- Takeda Pharmaceuticals (Boston, MA)
- …to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory ... Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. You will be RA CMC member… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Senior Associate - Specialist, Global Regulatory Affairs CMC role is within in the GRA Chemistry ... functions as follows: + With supervision, support the execution of regulatory CMC investigational, registration and post-approval strategies for assigned… more
- Actalent (Boston, MA)
- …Masters, PharmD, or PhD preferred. + Minimum of 8+ years of experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, ... regulatory professional eager to join a collaborative team as a Director/ Sr . Director of Regulatory CMC based in Boston with a hybrid option. This role… more
- Cardinal Health (Boston, MA)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product ... submissions within the discipline of chemistry, manufacturing, and controls ( CMC ). The _Sr. Coordinator, Regulatory Submissions Operations_ will use… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- Fresenius Medical Center (Waltham, MA)
- …(Advanced degree such as a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred. + **Experience:** + 12+ years ... portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership...of experience in regulatory affairs , focusing on regulatory … more
- Takeda Pharmaceuticals (Lexington, MA)
- …and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC , Marketing). + Minimum… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Clinical Research and program management experience working with clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... Medical IISR clinical trials in assigned TA. Ensure coordination with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from… more
- AbbVie (Cambridge, MA)
- …of Drug Development (eg, pre-clinical research, clinical development, Regulatory Affairs , Chemistry Manufacturing and Controls ( CMC )). + Experience with ... assessments of individual partnering opportunities to therapeutic area leadership and senior governance committees as well as contributing to Specialty and Discovery… more
- Takeda Pharmaceuticals (Boston, MA)
- …remote work allowed with 5 days/month onsite. **REQUIREMENTS:** Master's degree in Regulatory Affairs , Pharmacy, Biochemistry, Biology, or science related field ... following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Senior Research Associate **POSITION DESCRIPTION** : Takeda Development Center Americas,… more